Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications, 28322-28329 [2017-12908]
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
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The Agency encourages health care
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
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Dated: June 15, 2017.
Anna K. Abram,
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[FR Doc. 2017–12906 Filed 6–20–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3203]
Wyeth Pharmaceuticals Inc. et al.;
Withdrawal of Approval of 121 New
Drug Applications and 161 Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 121 new drug applications
(NDAs) and 161 abbreviated new drug
applications (ANDAs) from multiple
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
SUMMARY:
The withdrawal is effective on
July 21, 2017.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: The
holders of the applications listed in
table 1 in this document have informed
FDA that these drug products are no
longer marketed and have requested that
FDA withdraw approval of the
applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
DATES:
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
28323
TABLE 1
Application No.
Drug
Applicant
NDA 005897 ......
Folvite (folic acid) Injection, 5 milligrams (mg)/milliliter (mL) ...
NDA 006343 ......
Wydase (hyaluronidase) Injection USP ...................................
NDA 007390 ......
Banthine (methantheline bromide) Tablets, 50 mg .................
NDA 008126 ......
NDA 011683 ......
Cortisone Acetate (cortisone acetate) Tablets, 5 mg, 10 mg,
and 25 mg; and Injection, 25 mg/mL.
Pro-Banthine (propantheline bromide) Tablets, 7.5 mg and
15 mg.
Thiotepa for Injection, 15 mg/vial .............................................
Wyeth Pharmaceuticals Inc., Subsidiary of Pfizer Inc., P.O.
Box 8299, Philadelphia, PA 19101–8299.
Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake,
IL 60073.
Shire Development Inc., 725 Chesterbrook Blvd., Wayne, PA
19087.
Pharmacia & Upjohn Co., Subsidiary of Pfizer Inc., 235 East
42nd St., New York, NY 10017.
Shire Development Inc.
NDA 011836 ......
Presamine (imipramine hydrochloride (HCl)) Tablets USP .....
NDA 012003 ......
Akineton (biperiden HCl) Tablets, 2 mg ..................................
NDA 012421 ......
Medrol Acetate (methylprednisolone acetate) Topical Ointment, 0.25% and 1%.
Herplex (idoxuridine) Ophthalmic Solution, 0.1% ....................
NDA 008732 ......
NDA 013935 ......
NDA 013993 ......
NDA 014006 ......
NDA 014214 ......
NDA 014295 ......
NDA 016089 ......
Chromitope Sodium (sodium chromate Cr 51) Injection USP,
2 millicuries (mCi)/vial and 200 microcuries (uCi)/mL.
Maxibolin (ethylestrenol) Elixir, 2 mg/5 mL ..............................
NegGram (nalidixic acid) Tablets USP, 250 mg, 500 mg, and
1 gram (g).
Conray 400 (iothalamate sodium) Injection USP, 66.8% ........
NDA 016708 ......
Rubratope-57 (cyanocobalamin CO-57) Capsules, 0.5–1 uCi
and Rubratope-57 Kit (cobalt chloride CO-57, cyanocobalamin, cyanocobalamin CO-57, intrinsic factor).
Ovral (ethinyl estradiol and norgestrel) Tablets, 0.05 mg/0.5
mg.
M/6 Sodium Lactate (sodium lactate) Injection USP, 1.87 g/
100 mL.
Dextrose 10% and Sodium Chloride 0.9% Injection USP in
Plastic Container.
Sodium Chromate Cr 51 Injection, 100 μCi/mL .......................
NDA 016744 ......
Noriday 1+50 FE (mestranol and norethindrone) Tablets .......
NDA 016806 ......
NDA 016860 ......
Ovral-28 (ethinyl estradiol and norgestrel) Tablets, 0.05 mg/
0.5 mg.
Eskalith (lithium carbonate) Capsules, 300 mg .......................
NDA 017038 ......
Sodium Chloride Injection, 20 g/100 mL .................................
NDA 017281 ......
Technetium Tc99m Generator (Neutron) .................................
NDA 017283 ......
NDA 017505 ......
NDA 017549 ......
Xenon Xe 133 Injection, 6.3 mCi/mL .......................................
Noriday (mestranol and norethindrone) Tablets ......................
LidoPen (lidocaine HCl) Injection, 10% ...................................
NDA 017576 ......
Ovcon-50 (ethinyl estradiol and norethindrone ) Tablets USP,
0.05 mg/1 mg.
Sodium Chloride 0.45% in Plastic Container, Irrigation ..........
Tylenol (acetaminophen) Suppositories, 120 mg and 650 mg
NDA 016672 ......
NDA 016692 ......
NDA 016696 ......
NDA 017670 ......
NDA 017756 ......
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 017748 ......
NDA 018031 ......
NDA 018039 ......
NDA 018104 ......
NDA 018239 ......
NDA 018254 ......
NDA 018353 ......
NDA 018388 ......
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Noriday 1+50 (mestranol and norethindrone) Tablets .............
Inderide (propranolol HCl and hydrochlorothiazide) Tablets,
40 mg/25 mg and 80 mg/25 mg.
Loxitane IM (loxapine HCl) Injection, Equivalent to (EQ) 50
mg base/mL.
Hylorel (guanadrel sulfate) Tablets, 10 mg and 25 mg ...........
Propine (dipivefrin HCl) Ophthalmic Solution USP, 0.1% .......
Ringer’s and Dextrose 5% (calcium chloride, dextrose, potassium chloride, sodium chloride) Injection USP (in Plastic
Container).
Flagyl I.V. (metronidazole HCl) for Injection, EQ 500 mg
base/vial.
Lidocaine HCl in Dextrose 5% in Plastic Container Injection ..
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Immunex Corp., Subsidiary of Amgen, 1 Amgen Center Dr.,
MS 17 1B, Thousand Oaks, CA 91320–1799.
Sanofi-Aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ
08807.
AbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30–1,
North Chicago, IL 60064.
Pharmacia & Upjohn Co.
Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA
92623–9534.
Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H,
Monroe Township, NJ 08831.
Organon USA, Inc., Subsidiary of Merck & Co., Inc., 2000
Galloping Hill Rd., Kenilworth, NJ 07033.
Sanofi-Aventis U.S. LLC, c/o Sanofi U.S. Services Inc., 55
Corporate Dr., Bridgewater, NJ 08807.
Mallinckrodt Inc., 675 McDonnell Blvd., Hazelwood, MO
63042.
Bracco Diagnostics Inc.
Wyeth Pharmaceuticals Inc.
Baxter Healthcare Corp.
Do.
Mallinckrodt Nuclear Medicine LLC., 2703 Wagner Place,
Maryland Heights, MO 63043.
GD Searle LLC, Subsidiary of Pfizer Inc., 235 East 42nd St.,
New York, NY 10017.
Wyeth Pharmaceuticals Inc.
Noven Therapeutics, LLC., 11960 Southwest 144th St.,
Miami, FL 33186.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
Lantheus Medical Imaging, Inc., 331 Treble Cove Rd., North
Billerica, MA 01862.
Lantheus Medical Imaging, Inc.
GD Searle LLC.
Meridian Medical Technologies, Inc., Subsidiary of Pfizer
Inc., 235 East 42nd Street, New York, NY 10017.
Warner Chilcott Co., LLC, Union Street Road, 195 km 1.1,
Fajrado, Puerto Rico 00738.
Hospira, Inc. 275 North Field Dr., Lake Forest, IL 60045.
Johnson & Johnson Consumer Inc., McNeil Consumer
Healthcare Division, 7050 Camp Hill Rd., Fort Washington,
PA 19034.
GD Searle LLC.
Wyeth Pharmaceuticals Inc.
Actavis Laboratories UT, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044.
Pharmacia and Upjohn Co.
Allergan, Inc.
Hospira Inc.
GD Searle LLC.
Hospira, Inc.
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
TABLE 1—Continued
Application No.
Drug
NDA 018404 ......
NDA 018406 ......
0.25% Acetic Acid Irrigation Solution .......................................
PhysioSol (magnesium chloride, potassium chloride, sodium
acetate, sodium chloride, sodium gluconate) Irrigation Solution.
Dialyte (Peritoneal Dialysis Solution) Pattern LM (calcium
chloride, dextrose, magnesium chloride, sodium acetate,
sodium chloride) with Dextrose.
Soyacal (soybean oil) Injection, 10% .......................................
NDA 018460 ......
NDA 018465 ......
NDA 018509 ......
Applicant
NDA 018713 ......
Baros (sodium bicarbonate, tartaric acid) Effervescent Granules, 460 mg/g; 420 mg/g).
Mycelex (clotrimazole) Troche/Lozenge, 10 mg ......................
ANDA 018730 ....
Indomethacin Capsules USP, 25 mg and 50 mg ....................
NDA 018786 ......
Soyacal(Soybean Oil) Injection, 20% ......................................
NDA 018807 ......
Dialyte (Peritoneal Dialysis Concentrates) (calcium chloride,
dextrose, magnesium chloride, sodium acetate, sodium
chloride) with Dextrose.
Intal (cromolyn sodium) Metered Dose Inhaler, 0.8 mg/inhalation.
Liposyn III 20% (soybean oil) Injection ....................................
Liposyn II 20% (safflower oil and soybean oil) Injection .........
Liposyn II 10% (safflower oil and soybean oil) Injection .........
Calan (verapamil HCl) Injection, 2.5 mg/mL ............................
Bretylium Tosylate in 5% Dextrose Injection ...........................
Theophylline and 5% Dextrose Injection .................................
Zinc Sulfate Injection, EQ 1 mg Zinc/mL .................................
NDA 018887 ......
NDA
NDA
NDA
NDA
NDA
NDA
NDA
018970
018991
018997
019038
019121
019212
019229
......
......
......
......
......
......
......
NDA 019350 ......
NDA 019415 ......
NDA 019510 ......
Cupric Sulfate Injection, EQ 0.4 mg Copper/mL .....................
Fertinex (urofollitropin) for Subcutaneous Injection, 75 international units (IU)/ampule and 150 IU/ampule, and
Metrodin (urofollitropin) for Intramuscular Injection, 75 IU)/
ampule and 150 IU/ampule.
Pepcid (famotidine) Injection, 10 mg/mL .................................
NDA 019514 ......
NDA 019515 ......
NDA 019641 ......
Ionosol T and 5% Dextrose Injection .......................................
Ionosol B and 5% Dextrose Injection ......................................
Terazol 3 (terconazole) Vaginal Suppositories, 80 mg ...........
NDA 019643 ......
NDA 019660 ......
Mevacor (lovastatin) Tablets, 10 mg, 20 mg, and 40 mg .......
Tilade (nedocromil sodium) Metered Dose Inhaler, 1.75 mg/
inhalation.
Pharmaseal Scrub Care (chlorhexidine gluconate) Sponge,
4%.
Heparin Sodium in Sodium Chloride Injection .........................
Plendil (felodipine) Extended-Release Tablets, 2.5 mg, 5 mg,
and 10 mg.
Optipranolol (metipranolol HCl) Ophthalmic Solution, 0.3% ....
NDA 019793 ......
NDA 019802 ......
NDA 019834 ......
NDA 019907 ......
NDA 019933 ......
ANDA 020360 ....
NDA 020409 ......
Lactated Ringer’s (calcium chloride, potassium chloride, sodium chloride, sodium lactate) Irrigation Solution.
Dilacor XR (diltiazem HCl) Extended-Release Capsules, 120
mg, 180 mg, and 240 mg.
Nitrodisc (nitroglycerin) Transdermal System, 0.2 mg/hour
(hr), 0.3 mg/hr, and 0.4 mg/hr.
Liposyn III 30% (soybean oil) Injection ....................................
Pepcid Preservative Free (famotidine) Injection, 0.4 mg/mL ..
Combivent (albuterol sulfate and ipratropium bromide) Metered Dose Inhaler, EQ 0.09 mg base/inhalation; 0.018 mg/
inhalation.
FerriSeltz (ferric ammonium citrate) Powder for Oral Solution,
600 mg/packet.
Hepatasol Sulfite-free (amino acids) Injection, 8% ..................
Nasarel (flunisolide) Nasal Spray, 0.029 mg/spray .................
NDA 020448 ......
NDA 020506 ......
Imodium A–D (loperamide HCl) Tablets (Chewable), 2 mg ....
Tiamate (diltiazem malate) Extended-Release Tablets ...........
NDA 020092 ......
NDA 020146 ......
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 020181 ......
NDA 020249 ......
NDA 020291 ......
NDA 020292 ......
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Do.
Do.
B. Braun Medical Inc.
Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA
90032.
Mallinckrodt Inc.
Bayer Healthcare Pharmaceuticals Inc., 100 Bayer Blvd.,
Whippany, NJ 07981.
Zenith Laboratories, Inc., 140 LeGrand Ave., Northvale, NJ
07647.
Grifols Biologicals Inc., 5555 Valley Blvd., Los Angeles, CA
90032.
B. Braun Medical Inc.
King Pharmaceuticals Inc., Subsidiary of Pfizer Inc., 235 East
42nd St., New York, NY 10017.
Hospira, Inc.
Do.
Do.
G.D. Searle LLC.
B. Braun Medical Inc.
Do.
Abraxis Pharmaceutical Products, 6133 North River Rd.,
Suite 500, Rosemont, IL 60018.
Do.
EMD Serono, Inc., One Technology Pl., Rockland, MA
02370.
Merck Sharp & Dohme Corp., Subsidiary of Merck & Co.,
Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ
08889.
Hospira, Inc.
Do.
Janssen Pharmaceuticals, Inc., 1000 U.S. Highway 202,
Raritan, NJ 08869.
Merck Sharp & Dohme Corp.
King Pharmaceuticals Inc.
CareFusion 2200, Inc., 75 North Fairway Dr., Vernon Hills, IL
60061.
B. Braun Medical Inc.
AstraZeneca Pharmaceuticals LP, 1800 Concord Pike, Wilmington, DE 19803.
Bausch & Lomb, Inc., Subsidiary of Valeant Pharmaceuticals
International, Inc., 400 Somerset Corporate Blvd., Bridgewater, NJ 08807.
Baxter Healthcare Corp.
Allergan Sales, LLC, 2525 Dupont Drive, Irvine, CA 92612.
GD Searle LLC.
Hospira, Inc.
Merck Sharp & Dohme Corp.
Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury
Rd., P.O. Box 368, Ridgefield, CT 06877.
Otsuka Pharmaceutical Co., Ltd., 508 Carnegie Center Dr.,
Princeton, NJ 08540.
Baxter Healthcare Corp.
Teva Branded Pharmaceutical Products R&D, Inc., 74 NW
176th St., Miami, FL 33169.
Johnson & Johnson Consumer Inc.
Merck & Co., Inc., P.O. Box 1000, UG2C–50, North Wales,
PA 19454.
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TABLE 1—Continued
Application No.
Drug
Applicant
NDA 020518 ......
Retrovir (zidovudine) Tablets, 200 mg and 300 mg ................
NDA 020569 ......
NDA 020606 ......
Vitrasert (ganciclovir) Implant, 4.5 mg .....................................
Imodium Multi-Symptom Relief (loperamide HCl and simethicone) Tablets (Chewable), 2 mg/125 mg.
Levaquin (levofloxacin) Injection, EQ 250 mg/50 mL, EQ 500
mg/100 mL, and EQ 750 mg/150 mL.
Zantac (ranitidine HCl) Tablets (Effervescent), EQ 75 mg
base.
Pepcid RPD (famotidine) Orally Disintegrating Tablets, 20 mg
and 40 mg.
Floxin Otic (ofloxacin) Otic Solution, 0.3% ..............................
Klonopin (clonazepam) Orally Disintegrating Tablets, 0.125
mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg.
Pepcid AC (famotidine) Tablets OTC, 10 mg ..........................
Visicol (sodium phosphate, monobasic monohydrate, and sodium phosphate dibasic anhydrous) Tablets USP.
ViiV Healthcare Co., Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709.
Bausch & Lomb Inc.
Johnson & Johnson Consumer Inc.
NDA 020635 ......
NDA 020745 ......
NDA 020752 ......
NDA 020799 ......
NDA 020813 ......
NDA 020902 ......
NDA 021097 ......
NDA 021214 ......
Rescula (unoprostone isopropyl) Ophthalmic Solution, 0.15%
NDA 021224 ......
Razadyne (galantamine hydrobromide) Oral Solution, 4 mg/
mL.
Bayer Extra Strength Aspirin (aspirin) Tablets, 500 mg ..........
NDA 021317 ......
NDA 021412 ......
NDA 021453 ......
NDA 021483 ......
NDA 021494 ......
NDA 021589 ......
NDA 021595 ......
NDA 021721 ......
NDA 021763 ......
NDA 021864 ......
NDA 022103 ......
NDA 022220 ......
NDA 022294 ......
NDA 022377 ......
NDA 022411 ......
NDA 022494 ......
Kemstro (baclofen) Orally Disintegrating Tablets, 10 mg and
20 mg.
Sanctura (trospium chloride) Tablets, 20 mg ..........................
Levaquin (levofloxacin) Oral Solution, 25 mg/mL ....................
Citalopram Hydrobromide Orally Disintegrating Tablets, EQ
10 mg base, EQ 20 mg base, and EQ 40 mg base.
Lybrel (ethinyl estradiol and levonorgestrel) Tablets, 0.02 mg/
0.09 mg.
Sanctura XR (trospium chloride) Extended-Release Capsules, 60 mg.
Trivaris (triamcinolone acetonide) Injectable Suspension, 80
mg/mL.
Zidovudine Tablets, 60 mg ......................................................
Alsuma (sumatriptan succinate) Auto-Injector, EQ 6 mg base/
0.5 mL Injectable.
Oleptro (trazodone HCl) Extended-Release Tablets, 150 mg
and 300 mg.
Sodium Fluoride F 18 Injection, 10–200 mCi/mL ....................
ANDA 040032 ....
Tekamlo (aliskiren hemifumarate and amlodipine besylate)
Tablets.
Cyclophosphamide Tablets USP, 25 mg and 50 mg ..............
ANDA 040262 ....
Leucovorin Calcium for Injection, EQ 350 mg base/vial .........
ANDA 040772 ....
ANDA 040793 ....
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 022545 ......
Tovalt ODT (zolpidem tartrate) Orally Disintegrating Tablets,
5 mg and 10 mg.
Zerit XR (stavudine) Extended-Release Capsules, 37.5 mg,
50 mg, 75 mg, and 100 mg.
Geodon (ziprasidone HCl) Oral Suspension, EQ10 mg base/
mL.
Axid (nizatidine) Oral Solution, 15 mg/mL ...............................
Fluorouracil Injection USP, 50 mg/mL .....................................
A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 40 mg base/vial.
A-Methapred (methylprednisolone sodium succinate) for Injection USP, EQ 125 mg base/vial.
Erythrocin (erythromycin lactobionate) for Injection USP ........
Geocillin (carbenicillin indanyl sodium) Tablets, EQ 382 mg
base.
Duricef (cefadroxil) Tablets USP, EQ 1 g base .......................
ANDA 040827 ....
NDA 050182 ......
NDA 050435 ......
NDA 050528 ......
NDA 050545 ......
NDA 050590 ......
VerDate Sep<11>2014
Pipracil (piperacillin sodium) Injection ......................................
Timentin (ticarcillin disodium and clavulanate potassium) for
Injection.
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Janssen Pharmaceuticals, Inc.
Sanofi-Aventis U.S. LLC, 55 Corporate Drive, Bridgewater,
NJ 08807.
Merck Sharp & Dohme Corp.
Daiichi Sankyo Co., Ltd., 399 Thornall St., Edison, NJ 08837.
Hoffmann La-Roche, Inc., c/o Genentech, Inc., 1 DNA Way
MS #242, South San Francisco, CA 94080.
Johnson & Johnson Consumer Inc.
Salix Pharmaceuticals Inc., Subsidiary of Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
R-Tech Ueno, Ltd., c/o Sucampo Pharma Americas, LLC,
805 King Farm Blvd., Suite 550, Rockville, MD 20850.
Janssen Pharmaceuticals, Inc.
Bayer Healthcare LLC, 100 Bayer Blvd., Whippany, NJ
07981.
Valeant Pharmaceuticals North America, LLC, 400 Somerset
Corporate Blvd., Bridgewater, NJ 08807.
Bristol-Myers Squibb Co., 5 Research Parkway, Wallingford,
CT 06492.
Pfizer Inc., 235 East 42nd St., New York, NY 10017.
Braintree Laboratories, Inc., 60 Columbian St. West, P.O.
Box 850929, Braintree, MA 02185.
UCB, Inc.,1950 Lake Park Dr., Smyrna, GA 30080.
Allergan, Inc.
Janssen Pharmaceuticals, Inc.
Valeant International (Barbados)
Church, Barbados, BB17154.
Wyeth Pharmaceuticals Inc.
SRL
Welches,
Christ
Allergan, Inc.
Do.
Aurobindo Pharma Limited, c/o Aurobindo Pharma USA, Inc.,
2400 Route 130 North, Dayton, NJ 08810.
Meridian Medical Technologies, Inc., 1945 Craig Rd., St.
Louis, MO 63146.
Angelini Pharma Inc., 8322 Helgerman Ct., Gaithersburg, MD
20877.
National Institutes of Health/National Cancer Institute, Cancer
Imaging Program, 9609 Medical Center Dr., Room 4–
W236, MSC 9729, Bethesda, MD 20892–9729.
Novartis Pharmaceuticals Corp., One Health Plaza, East
Hanover, NJ 07936.
Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH
43228.
Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19
Hughes, Irvine, CA 92618.
Sandoz Inc., 100 College Road West, Princeton, NJ 08540.
Hospira, Inc.
Do.
Do.
Pfizer, Inc.
Warner Chilcott Co., Inc., 100 Enterprise Drive, Rockaway,
NJ 07866.
Wyeth Pharmaceuticals Inc.
GlaxoSmithKline.
E:\FR\FM\21JNN1.SGM
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
TABLE 1—Continued
Application No.
Drug
NDA 050658 ......
Timentin Galaxy Plastic Container(ticarcillin disodium and
clavulanate potassium) for Injection.
Cefzil (cefprozil) Tablets, 250 mg and 500 mg .......................
NDA 050664 ......
NDA 050665 ......
ANDA 060076 ....
ANDA 060111 ....
ANDA 060607 ....
ANDA 061578 ....
ANDA 061580 ....
ANDA 061645 ....
ANDA 061648 ....
ANDA 062118 ....
ANDA 062206 ....
ANDA 062339 ....
ANDA 062523 ....
ANDA 062628 ....
ANDA 062691 ....
ANDA 062714 ....
ANDA 062721 ....
ANDA 062822 ....
ANDA 063176 ....
ANDA 063208 ....
ANDA 063216 ....
ANDA 063283 ....
ANDA 064169 ....
Cefzil (cefprozil) Oral Suspension, 125 mg/5 mL and 250 mg/
5 mL.
Streptomycin Sulfate Powder for Injection, EQ 1 g base/vial
and EQ 5 g base/vial.
Streptomycin Sulfate Powder for Injection, EQ 1 g base/2.5
mL.
Neomycin Sulfate Tablets, 500 mg ..........................................
Poly-Rx (polymyxin B sulfate USP) for Prescription
Compounding.
Baci-Rx (bacitracinUSP) for Prescription Compounding .........
Econochlor (chloramphenicol) Ophthalmic Solution USP,
0.5%.
Chloramphenicol Ophthalmic Ointment, 1% ............................
Cephalexin Capsules USP, EQ 250 mg base and EQ 500
mg base.
Cefaclor for Oral Suspension USP, EQ 125 mg base/5 mL,
EQ 187 mg base/5 mL, EQ 250 mg base/5 mL, and EQ
375 mg base/5 mL.
Statrol (neomycin sulfate and polymyxin B sulfate) Ophthalmic Solution, EQ 3.5 mg base/mL and 16,250 units/mL.
Gentamicin Sulfate Ophthalmic Solution USP, EQ 0.3% base
Chloramphenicol Ophthalmic Solution USP, 0.5% ..................
Timentin ADD-Vantage (ticarcillin disodium and clavulanate
potassium) for Injection USP, EQ 3 g base/vial and EQ
100 mg base/vial.
Neomycin Sulfate and Dexamethasone Sodium Phosphate
Ophthalmic Solution, EQ 3.5 mg base/mL and EQ 0.1%
and.
Neomycin and Polymyxin B Sulfate and Dexamethasone
Ophthalmic Suspension USP, EQ 3.5 mg base/mL; 10,000
units/mL; 0.1%.
Pediotic (neomycin sulfate and polymyxin B sulfate and hydrocortisone) Otic Suspension USP.
Tobramycin Ophthalmic Solution USP, 0.3% ..........................
Cefazolin for Injection USP, EQ 1 g base/100 mL vial ...........
ANDA 065475 ....
ANDA 070088 ....
ANDA 070187 ....
Cefazolin for Injection USP, EQ 500 mg base/100 mL vial ....
Amikacin Sulfate Injection, EQ 62.5 mg base/mL ...................
Cefazolin for Injection USP, EQ 500 mg base/vial and EQ 1
g base/vial.
Cefazolin for Injection USP, EQ 10 g base/vial and EQ 20 g
base/vial.
Neo-Fradin (neomycin sulfate) Oral Solution USP, EQ 87.5
mg base/5 mL.
Cefoxitin (cefoxitin sodium) for Injection, EQ 10 g base/Vial ..
Cefoxitin for Injection USP, EQ 1 g base/vial and EQ 2 g
base/vial.
Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500
mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial.
Ceftriaxone for Injection, EQ 10 g base/vial ............................
Amoxicillin Tablets for Oral Suspension USP, 200 mg and
400 mg.
Epirubicin HCl Injection, 50 mg/25 mL and 200 mg/100 mL ..
Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500
mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial.
Ceftriaxone for Injection USP, EQ 10 g base/vial ...................
Ibuprofen Tablets USP, 600 mg ..............................................
Disopyramide Phosphate Capsules USP, EQ 150 mg base ..
ANDA 070587 ....
ANDA 070659 ....
Bupivacaine HCl Injection USP, 0.75% ...................................
Clonidine HCl Tablets, 0.3 mg .................................................
ANDA 070702 ....
ANDA 070747 ....
ANDA 070804 ....
Clonidine HCl Tablets, 0.2 mg .................................................
Clonidine HCl Tablets, 0.1 mg .................................................
Metaproterenol Sulfate Inhalation Solution USP, 0.6% ...........
ANDA 071067 ....
Methyldopa Tablets USP, 500 mg ...........................................
ANDA 064170 ....
ANDA 065010 ....
ANDA 065011 ....
ANDA 065012 ....
ANDA 065245 ....
ANDA 065252 ....
ANDA 065324 ....
ANDA 065339 ....
ANDA 065465 ....
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Applicant
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Do.
Corden Pharma Latina, S.p.A. , c/o Clinipace, Inc., 4840
Pearl East Circle, Suite 210E, Boulder, CO 80301.
Do.
Pfizer Inc.
Do.
Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136.
X–GEN Pharmaceuticals, Inc., 300 Daniel Zenker Dr., Horseheads, NY 14845.
Do.
Alcon Laboratories, Inc., 6201 South Freeway, TC–45, Fort
Worth, TX 76134–2099.
Do.
Do.
Do.
Alcon Laboratories, Inc.
Do.
Do.
GlaxoSmithKline.
Alcon Pharmaceuticals Ltd., 6201 South Freeway, Fort
Worth, TX 76134.
Do.
Monarch Pharmaceuticals, Inc., Subsidiary of Pfizer Inc., 235
East 42nd St., New York, NY 10017–7555.
Alcon Pharmaceuticals, Ltd.
Steri-Pharma, LLC, 429 South West St., Syracuse, NY
13202.
Do.
Hospira, Inc.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
Do.
X–GEN Pharmaceuticals, Inc.
Fresenius Kabi USA, LLC.
Do.
Do.
Do.
Aurobindo Pharma Limited.
Sandoz, Inc.
Bedford Laboratories, c/o PAREXEL International, 4600
East-West Highway, Suite 350, Bethesda, MD 20814.
Do.
BASF Corp., 5738 County Rd. 4, Bishop, TX 78343.
Ivax Pharmaceuticals Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Road, Horsham, PA 19044.
Hospira, Inc.
Teva Pharmaceuticals USA Inc., 1090 Horsham Rd., P.O.
Box 1090, North Wales, PA 19454.
Do.
Do.
Mylan Specialty, L.P., 781 Chestnut Ridge Rd., P.O. Box
4310, Morgantown, WV 26504.
Teva Pharmaceuticals USA, Inc.
E:\FR\FM\21JNN1.SGM
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28327
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 071101 ....
Clonidine HCl Tablets USP, 0.3 mg ........................................
ANDA
ANDA
ANDA
ANDA
ANDA
071102
071103
071105
071106
071426
....
....
....
....
....
Clonidine HCl Tablets USP, 0.2 mg ........................................
Clonidine HCl Tablets USP, 0.1 mg ........................................
Methyldopa Tablets USP, 125 mg ...........................................
Methyldopa Tablets USP, 250 mg ...........................................
Vincasar PFS (vincristine sulfate) Injection USP, 1 mg/mL ....
ANDA
ANDA
ANDA
ANDA
ANDA
071584
071786
072323
072324
073034
....
....
....
....
....
Diazepam Injection USP, 5 mg/mL ..........................................
Metaproterenol Sulfate Inhalation Solution USP, 0.4% ...........
Acetylcysteine Solution USP, 10% ..........................................
Acetylcysteine Solution USP, 20% ..........................................
Metaproterenol Sulfate Oral Solution USP, 10 mg/5 mL ........
ANDA
ANDA
ANDA
ANDA
ANDA
073636
073676
074023
074160
074269
....
....
....
....
....
ANDA 074300 ....
ANDA 074396 ....
Dipivefrin HCl Ophthalmic Solution USP, 0.1% .......................
Atenolol Tablets, 50 mg and 100 mg ......................................
Ranitidine Tablets USP, 150 mg and 300 mg .........................
Bumetanide Injection USP, 0.25 mg/mL ..................................
Cimetidine in Sodium Chloride 0.9% Injection USP, EQ6 mg
base/mL).
Lorazepam Injection USP, 2 mg/mL and 4 mg/mL .................
Enflurane Inhalation , 99.9% ....................................................
Duramed Pharmaceuticals, Inc., 2 Quaker Rd., P.O. Box
2900, Pomona, NY 10970.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
Teva Parenteral Medicines Inc., 19 Hughes, Irvine, CA
92618.
Hospira, Inc.
Mylan Specialty L.P.
Roxane Laboratories, Inc.
Do.
G&W Laboratories Inc., 111 Coolidge St., South Plainfield,
NJ 07080.
Alcon Pharmaceuticals, Ltd.
GD Searle LLC.
Mylan Pharmaceuticals Inc.
Hospira, Inc.
Do.
ANDA
ANDA
ANDA
ANDA
....
....
....
....
Clozapine Tablets USP, 25 mg and 100 mg ...........................
Atracurium Besylate Injection, 10 mg/mL ................................
Levobunolol HCl Ophthalmic Solution USP, 0.25% ................
Etodolac Tablets USP, 400 mg ...............................................
ANDA 075117 ....
ANDA 075436 ....
Orapred (prednisolone sodium phosphate) Oral Solution, EQ
15 mg base/5 mL.
Paclitaxel Injection USP, 6 mg/mL ..........................................
ANDA 075721 ....
ANDA 075963 ....
ANDA 076234 ....
Leuprolide Acetate Injection, 1 mg/0.2 mL ..............................
Tramadol HCl Tablets, 50 mg ..................................................
Flavoxate HCl Tablets, 100 mg ...............................................
ANDA 076296 ....
ANDA 076394 ....
Vincristine Sulfate Injection USP, 1 mg/mL .............................
Amiodarone HCl Injection, 50 mg/mL ......................................
ANDA 076401 ....
ANDA 076414 ....
Vincristine Sulfate Injection USP, 1 mg/mL .............................
Milrinone Lactate in 5% Dextrose Injection, EQ 20 mg base/
100 mL.
Diltiazem HCl Extended-Release Capsules USP, 120 mg,
180 mg, 240 mg, 300 mg, 360 mg, 420 mg.
Parcopa (carbidopa and levodopa) Orally Disintegrating Tablets, 10 mg/100 mg, 25 mg/100 mg, and 25 mg/250 mg.
Didanosine Tablets for Oral Suspension USP, 100 mg, 150
mg, and 200 mg.
Stavudine for Oral Solution USP, 1 mg/mL .............................
Carvedilol Tablets USP, 3.125 mg, 6.25 mg, 12.5 mg, 25 mg
074546
074632
074851
074927
ANDA 076563 ....
ANDA 076699 ....
ANDA 077275 ....
ANDA 077774 ....
ANDA 077887 ....
ANDA 077968 ....
ANDA 078112 ....
ANDA 078240 ....
Alprazolam Extended-Release Tablets, 0.5 mg, 1 mg, 2 mg,
and 3 mg.
Alprazolam Extended-Release Tablets, 0.5 mg, 1 mg, 2 mg,
3 mg.
Didanosine for Oral Solution USP, 10 mg/mL .........................
Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg, and 25 mg
ANDA 078254 ....
Atenolol Tablets USP, 25 mg, 50 mg, and 100 mg ................
ANDA 078285 ....
ANDA 078298 ....
Bicalutamide Tablets USP, 50 mg ...........................................
Sumatriptan Succinate Tablets USP, EQ 25 mg base, EQ 50
mg base, EQ 100 mg base.
Lamotrigine Tablets USP, 25 mg, 100 mg, 150 mg, and 200
mg.
Granisol (granisetron HCl Oral Solution, 2 mg base/10mL .....
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 077996 ....
ANDA 078310 ....
ANDA 078334 ....
ANDA 078374 ....
ANDA 078408 ....
VerDate Sep<11>2014
Metoclopramide Tablets USP, EQ 5 mg base and EQ 10 mg
base.
Vinorelbine Injection USP, EQ 10 mg base/mL ......................
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Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem,
PA 18017.
Sandoz, Inc.
Hospira, Inc.
Alcon Laboratories, Inc.
Lehigh Valley Technologies, Inc., 514 North 12th St., Allentown, PA 18102.
Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343
Alexandria Dr., Suite 100, Lexington, KY 40504.
Accord Healthcare Inc., 1009 Slater Rd., Suite 210–B, Durham, NC 27703.
Genzyme Corp., 500 Kendall St., Cambridge, MA 02142.
Ivax Pharmaceuticals Inc.
Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
Fresenius Kabi USA, LLC.
Par Sterile Products, LLC, Morris Corporate Center 2, One
Upper Pond Rd., Parsippany, NJ 07054.
Fresenius Kabi USA, LLC.
B. Braun Medical Inc.
Nesher Pharmaceuticals (USA) LLC, 13910 St. Charles Rock
Rd., Bridgeton, MO 63044.
UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA
30080.
Aurobindo Pharma Limited.
Do.
Hikma Pharmaceuticals, c/o West-Ward Pharmaceuticals
Corp., 401 Industrial Way West, Eatontown, NJ 07724.
Impax Laboratories, Inc.
Do.
Aurobindo Pharma Limited.
Pliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceutical Industries Ltd., 425 Privet Rd., Horsham, PA 19044.
Northstar Healthcare Holdings, c/o Quality Regulatory Consultants, 1966 Anglers Cove, Vero Beach, FL 32963.
Roxane Laboratories, Inc.
Hikma Pharmaceuticals.
Pharmascience Inc., c/o Pharmascience Laboratories Inc.,
295 Firetower Rd., Tonawanda, NY 14150.
PediatRx, Inc., c/o Cardinal Health Regulatory Sciences,
7400 West 110th St., Commerce Plaza II, Suite 300, Overland Park, KS 66210.
Northstar Healthcare Holdings.
Sandoz Inc.
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 078501 ....
Dronabinol Capsules USP, 2.5 mg, 5 mg, and 10 mg ............
ANDA 078577 ....
Levofloxacin Injection, EQ 750 mg/30 mL and EQ 500 mg/20
mL.
Gabapentin Tablets USP, 600 mg and 800 mg ......................
Granisetron HCl Injection USP, EQ 0.1 mg base/mL .............
Oxaliplatin Injection USP, 50 mg/10 mL and 100 mg/20 mL ..
Glimepiride Tablets USP, 1 mg, 2 mg, and 4 mg ...................
Fomepizole Injection, 1.5 g/1.5 mL ..........................................
Insys Therapeutics, Inc., 1333 South Spectrum Blvd., Suite
100, Chandler, AZ 85286.
Hospira Inc.
ANDA
ANDA
ANDA
ANDA
ANDA
078782
078808
078812
078952
079033
....
....
....
....
....
ANDA 080020 ....
ANDA 080021 ....
ANDA 080229 ....
ANDA 080248 ....
ANDA 080472 ....
ANDA 080473 ....
ANDA 081043 ....
ANDA 081044 ....
ANDA 083205 ....
ANDA 083342 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
084645
084927
084928
085000
085014
085095
085294
085380
....
....
....
....
....
....
....
....
ANDA 085734 ....
ANDA 085981 ....
ANDA 085982 ....
ANDA 085995 ....
ANDA 086535 ....
ANDA 086911 ....
ANDA 087547 ....
ANDA 087771 ....
ANDA 087907 ....
Hytone (hydrocortisone) Lotion, 1% and 2.5% ........................
Prednisolone Sodium Phosphate Ophthalmic Solution USP,
EQ 0.11% phosphate.
Prednisolone Sodium Phosphate Ophthalmic Solution USP,
EQ 0.9% phosphate.
Orabase HCA (hydrocortisone acetate) Topical Paste, 0.5%
Maxidex (dexamethasone sodium phosphate) Ophthalmic
Ointment, EQ 0.05% phosphate.
Chlordiazepoxide HCl Capsules USP, 25 mg .........................
Methocarbamol Tablets USP, 500 mg .....................................
Methocarbamol Tablets USP, 750 mg .....................................
Chlordiazepoxide HCl Capsules USP, 10 mg .........................
Chlordiazepoxide HCl Capsules USP, 5 mg ...........................
Statobex-G (phendimetrazine tartrate) Tablets, 35 mg ...........
Chlordiazepoxide HCl Capsules USP, 25 mg .........................
Butisol Sodium (butabarbital sodium) Oral Solution USP, 30
mg/5 mL.
Ammonium Chloride Injection USP, 40 mEQ/100 mL .............
Hydrocortisone Acetate USP Micronized for Prescription
Compounding, 100%.
Hydro-Rx (hydrocortisone) USP Micronized for Prescription
Compounding, 100%.
Pediatric LTA Kit (lidocaine HCl) Topical Solution USP, 2% ..
Acticort (hydrocortisone) Lotion USP, 1% ...............................
Phentermine HCl Capsules USP, 30 mg .................................
Isopto Cetapred (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment USP, 10%/0.25%.
Cetapred (sulfacetamide sodium and prednisolone acetate)
Ophthalmic Ointment USP, 10%/0.25%.
Epinephrine Inhalation Aerosol USP, 0.2 mg/inhalation) ........
ANDA 088631 ....
ANDA 088632 ....
ANDA 088797 ....
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 088613 ....
ANDA 088614 ....
ANDA 088630 ....
Isopto Cetamide (sulfacetamide sodium) Ophthalmic Solution, 15%.
Sulfacetamide Sodium Ophthalmic Ointment, 10% .................
Naphcon Forte (naphazoline HCl) Ophthalmic Solution USP
0.1%.
Albalon (naphazoline HCl) Ophthalmic Solution USP, 0.1% ...
Hytone (hydrocortisone) Cream, 1% and 2.5% .......................
Phentermine HCl Capsules USP, 30 mg .................................
Phentermine HCl Capsules USP, 30 mg .................................
Pseudoephedrine HCl and Triprolidine HCl Tablets, 60 mg/
2.5 mg.
Butabarbital Sodium Tablets, 30 mg .......................................
Butabarbital Sodium Tablets, 15 mg .......................................
Phentermine HCl Capsules USP, 30 mg .................................
ANDA 088910 ....
ANDA 088917 ....
ANDA 088999 ....
Phentermine HCl Tablets USP, 37.5 mg .................................
Phentermine HCl Tablets USP, 37.5 .......................................
Dipyridamole Tablets USP, 25 mg ..........................................
ANDA
ANDA
ANDA
ANDA
ANDA
....
....
....
....
....
Dipyridamole Tablets USP, 50 mg ..........................................
Dipyridamole Tablets USP, 75 mg ..........................................
Sulfacetamide Sodium Ophthalmic Solution, 30% ..................
Tropicamide Ophthalmic Solution, 1% .....................................
Imipramine HCl Tablets USP, 10 mg ......................................
ANDA 089440 ....
Hydrocortisone Acetate and Pramoxine HCl Topical Aerosol,
1%/1%.
089000
089001
089068
089172
089422
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Hikma Pharmaceuticals.
Sandoz Inc.
Do.
Hikma Pharmaceuticals.
Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL
61103.
Alcon Laboratories, Inc.
Do.
Do.
Allergan, Inc.
Valeant International (Barbados) SRL, c/o Valeant Pharmaceuticals North America LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
Do.
Alcon Pharmaceuticals, Ltd.
Do.
Colgate-Palmolive Co., 909 River Rd., P.O. Box 1343,
Piscataway, NJ 08855–1343.
Alcon Laboratories, Inc.
Upsher-Smith Laboratories, Inc.
Impax Laboratories, Inc.
Do.
Hikma Pharmaceuticals.
Do.
Teva Pharmaceuticals USA, Inc.
Hikma Pharmaceuticals.
Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite #4300,
Somerset, NJ 08873.
B. Braun Medical Inc.
X-Gen Pharmaceuticals, Inc.
Do.
Hospira, Inc.
Baker Norton Pharmaceuticals Inc., 8800 N.W. 36 St., Miami,
FL 33178–2404.
Teva Pharmaceuticals USA, Inc.
Alcon Laboratories, Inc.
Do.
Armstrong Pharmaceuticals, Inc., 25 John Rd., Canton MA
02021.
Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
Do.
USL Pharma Inc., 301 South Cherokee St., Denver, CO
80223
Do.
Do.
Glenmark Generics Limited, c/o Glenmark Generics Inc.,
USA, 750 Corporate Dr., Mahwah, NJ 07430.
Do.
Do.
Alcon Pharmaceuticals, Ltd.
Do.
Par Pharmaceutical Inc., One Ram Ridge Rd., Spring Valley,
NY 10977.
Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL
35811.
E:\FR\FM\21JNN1.SGM
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Federal Register / Vol. 82, No. 118 / Wednesday, June 21, 2017 / Notices
28329
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 089497 ....
ANDA 089628 ....
Imipramine HCl Tablets USP, 25 mg ......................................
Leucovorin Calcium for Injection, EQ 50 mg base/vial ...........
ANDA 089681 ....
Bromfed-DM (brompheniramine maleate, dextromethorphan
hydrobromide, and pseudoephedrine HCl) Syrup, 2 mg/5
mL; 10mg/5 mL; 30mg/5 mL.
Leucovorin Calcium for Injection, EQ 100 mg base/vial .........
Tretinoin Cream USP, 0.0375% ..............................................
Irinotecan HCl Injection, 40 mg/2 mL and 100 mg/5 mL ........
Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5
mg, 0.75 mg, 1 mg, and 1.5 mg.
Adenosine Injection USP, 3 mg/mL .........................................
Par Pharmaceutical Inc.
Pharmachemie USA Inc., 323 Davis St., Northborough, MA
01532.
Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc.,
6451 Main St., Morton Grove, IL 60053.
ANDA
ANDA
ANDA
ANDA
089915
090098
090137
090190
....
....
....
....
ANDA 090220 ....
ANDA 090300 ....
ANDA 090751 ....
ANDA 090985 ....
ANDA 090986 ....
ANDA 091068 ....
ANDA 091185 ....
Children’s Cetirizine HCl Allergy and Hives Relief Oral Solution OTC, 5 mg/5 mL.
Cetirizine HCl Oral Solution USP, 5 mg/5 mL .........................
Octreotide Acetate Preservative Free Injection EQ 0.05 mg
base/mL, EQ 0.1 mg base/mL, and EQ 0.5 mg base/mL.
Octreotide Acetate Injection EQ 0.2 mg base/mL and EQ 1
mg base/mL.
Ceftriaxone for Injection USP, EQ 10 g base/vial ...................
ANDA 201211 ....
Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200
mg.
Idarubicin HCl Injection, 1 mg/mL ............................................
Fluorouracil Injection USP, 2.5 g/50 mL and 5 g/100 mL .......
Amturnide
(aliskiren
hemifumarate,
amlodipine,
andhydrochlorothiazide) Tablets.
Doxorubicin HCl Injection USP, 2 mg/mL ................................
Topotecan Injection, EQ 1 mg base/mL, EQ 3 mg base/3
mL, and EQ 4 mg base/4 mL.
Bromfenac Sodium Ophthalmic Solution, EQ 0.09% acid ......
NDA 201917 ......
Incivek (telaprevir) Tablets, 375 mg ........................................
NDA 202088 ......
Suprenza (phentermine HCl) Orally Disintegrating Tablets, 15
mg, 30 mg, and 37.5 mg.
Tretinoin Cream USP, 0.075% ................................................
Gelnique (oxybutynin) Gel, 3% ................................................
Suclear (magnesium sufate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, and sodium sulfate) Oral Solution.
Clinolipid 20% (olive oil and soybean oil) USP, 16%/4% ........
Dutrebis (lamivudine and raltegravir potassium) Tablets, 150
mg/EQ 300 mg base.
ANDA 091293 ....
ANDA 091299 ....
NDA 200045 ......
ANDA 200146 ....
NDA 200199 ......
ANDA 202209 ....
NDA 202513 ......
NDA 203595 ......
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 204508 ......
NDA 206510 ......
Therefore, under authority delegated
to the Director, Center for Drug
Evaluation and Research, by the
Commissioner, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in table 1 that
are in inventory on the date that this
notice becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
19:12 Jun 20, 2017
Jkt 241001
Pharmachemie USA Inc.
Allergan Sales, LLC.
Sandoz Inc.
Do.
Wockhardt Limited, c/o Wockhardt USA LLC, 20 Waterview
Blvd., 3rd Floor, Parsippany, NJ 07054.
Cypress Pharmaceutical, Inc., 10 North Park Place, Suite
210, Morristown, NJ 07960.
Aurobindo Pharma Limited.
Wockhardt Limited.
Do.
Agila Specialties Private Limited, c/o Agila Specialties Inc.,
201 South Main St., Suite 3, Lambertville, NJ 08530.
Hikma Pharmaceuticals.
Sandoz Inc.
Do.
Novartis Pharmaceuticals Corp.
Sandoz Inc.
Do.
Coastal Pharmaceuticals, 1240 Sugg Parkway, Greenville,
NC 27834.
Vertex Pharmaceuticals, Inc., 50 Northern Ave., Boston, MA
02210.
Citius Pharmaceuticals, LLC, 11 Commerce Dr., First Floor,
Cranford, NJ 07016.
Allergan Sales, LLC.
Do.
Braintree Laboratories, Inc.
Baxter Healthcare Corp.
Merck Sharp & Dohme Corp.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12908 Filed 6–20–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[CFDA Number: 93.085]
Awards Unsolicited Proposal for the
Professionalism and Integrity in
Research Program
Notice of award of a singlesource unsolicited grant to Washington
University in St. Louis, Missouri.
ACTION:
The Office of Research
Integrity (ORI) announces the award of
a single-source, grant in response to an
unsolicited proposal from Washington
University, St. Louis, Missouri. The
proposal submitted was not solicited
either formally or informally by any
federal government official.
FOR FURTHER INFORMATION CONTACT:
Kathryn Partin at kathryn.partin@
hhs.gov or by telephone at 240–453–
8200.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Office of Research Integrity,
Office of the Assistant Secretary for
Health, Department of Health and
Human Services.
AGENCY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Recipient: Washington University, St.
Louis, Missouri.
Purpose of the Award: Grant to
provide remediation training through
E:\FR\FM\21JNN1.SGM
21JNN1
]]>Agencies
[Federal Register Volume 82, Number 118 (Wednesday, June 21, 2017)]
[Notices]
[Pages 28322-28329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12908]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3203]
Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121
New Drug Applications and 161 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 121 new drug applications (NDAs) and 161 abbreviated new drug
applications (ANDAs) from multiple applicants. The holders of the
applications notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.
DATES: The withdrawal is effective on July 21, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
table 1 in this document have informed FDA that these drug products are
no longer marketed and have requested that FDA withdraw approval of the
applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)).
The applicants have also, by their requests, waived their opportunity
for a hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
[[Page 28323]]
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 005897............. Folvite (folic acid) Wyeth Pharmaceuticals
Injection, 5 Inc., Subsidiary of
milligrams (mg)/ Pfizer Inc., P.O. Box
milliliter (mL). 8299, Philadelphia,
PA 19101-8299.
NDA 006343............. Wydase (hyaluronidase) Baxter Healthcare
Injection USP. Corp., 32650 N.
Wilson Rd., Round
Lake, IL 60073.
NDA 007390............. Banthine (methantheline Shire Development
bromide) Tablets, 50 Inc., 725
mg. Chesterbrook Blvd.,
Wayne, PA 19087.
NDA 008126............. Cortisone Acetate Pharmacia & Upjohn
(cortisone acetate) Co., Subsidiary of
Tablets, 5 mg, 10 mg, Pfizer Inc., 235 East
and 25 mg; and 42nd St., New York,
Injection, 25 mg/mL. NY 10017.
NDA 008732............. Pro-Banthine Shire Development Inc.
(propantheline
bromide) Tablets, 7.5
mg and 15 mg.
NDA 011683............. Thiotepa for Injection, Immunex Corp.,
15 mg/vial. Subsidiary of Amgen,
1 Amgen Center Dr.,
MS 17 1B, Thousand
Oaks, CA 91320-1799.
NDA 011836............. Presamine (imipramine Sanofi-Aventis U.S.
hydrochloride (HCl)) LLC, 55 Corporate
Tablets USP. Dr., Bridgewater, NJ
08807.
NDA 012003............. Akineton (biperiden AbbVie Inc., 1 N.
HCl) Tablets, 2 mg. Waukegan Rd., Dept.
PA77/Bldg. AP30-1,
North Chicago, IL
60064.
NDA 012421............. Medrol Acetate Pharmacia & Upjohn Co.
(methylprednisolone
acetate) Topical
Ointment, 0.25% and 1%.
NDA 013935............. Herplex (idoxuridine) Allergan, Inc., 2525
Ophthalmic Solution, Dupont Dr., P.O. Box
0.1%. 19534, Irvine, CA
92623-9534.
NDA 013993............. Chromitope Sodium Bracco Diagnostics
(sodium chromate Cr Inc., 259 Prospect
51) Injection USP, 2 Plains Rd., Bldg. H,
millicuries (mCi)/vial Monroe Township, NJ
and 200 microcuries 08831.
(uCi)/mL.
NDA 014006............. Maxibolin Organon USA, Inc.,
(ethylestrenol) Subsidiary of Merck &
Elixir, 2 mg/5 mL. Co., Inc., 2000
Galloping Hill Rd.,
Kenilworth, NJ 07033.
NDA 014214............. NegGram (nalidixic Sanofi-Aventis U.S.
acid) Tablets USP, 250 LLC, c/o Sanofi U.S.
mg, 500 mg, and 1 gram Services Inc., 55
(g). Corporate Dr.,
Bridgewater, NJ
08807.
NDA 014295............. Conray 400 (iothalamate Mallinckrodt Inc., 675
sodium) Injection USP, McDonnell Blvd.,
66.8%. Hazelwood, MO 63042.
NDA 016089............. Rubratope-57 Bracco Diagnostics
(cyanocobalamin CO-57) Inc.
Capsules, 0.5-1 uCi
and Rubratope-57 Kit
(cobalt chloride CO-
57, cyanocobalamin,
cyanocobalamin CO-57,
intrinsic factor).
NDA 016672............. Ovral (ethinyl Wyeth Pharmaceuticals
estradiol and Inc.
norgestrel) Tablets,
0.05 mg/0.5 mg.
NDA 016692............. M/6 Sodium Lactate Baxter Healthcare
(sodium lactate) Corp.
Injection USP, 1.87 g/
100 mL.
NDA 016696............. Dextrose 10% and Sodium Do.
Chloride 0.9%
Injection USP in
Plastic Container.
NDA 016708............. Sodium Chromate Cr 51 Mallinckrodt Nuclear
Injection, 100 Medicine LLC., 2703
[micro]Ci/mL. Wagner Place,
Maryland Heights, MO
63043.
NDA 016744............. Noriday 1+50 FE GD Searle LLC,
(mestranol and Subsidiary of Pfizer
norethindrone) Tablets. Inc., 235 East 42nd
St., New York, NY
10017.
NDA 016806............. Ovral-28 (ethinyl Wyeth Pharmaceuticals
estradiol and Inc.
norgestrel) Tablets,
0.05 mg/0.5 mg.
NDA 016860............. Eskalith (lithium Noven Therapeutics,
carbonate) Capsules, LLC., 11960 Southwest
300 mg. 144th St., Miami, FL
33186.
NDA 017038............. Sodium Chloride B. Braun Medical Inc.,
Injection, 20 g/100 mL. 901 Marcon Blvd.,
Allentown, PA 18109.
NDA 017281............. Technetium Tc99m Lantheus Medical
Generator (Neutron). Imaging, Inc., 331
Treble Cove Rd.,
North Billerica, MA
01862.
NDA 017283............. Xenon Xe 133 Injection, Lantheus Medical
6.3 mCi/mL. Imaging, Inc.
NDA 017505............. Noriday (mestranol and GD Searle LLC.
norethindrone) Tablets.
NDA 017549............. LidoPen (lidocaine HCl) Meridian Medical
Injection, 10%. Technologies, Inc.,
Subsidiary of Pfizer
Inc., 235 East 42nd
Street, New York, NY
10017.
NDA 017576............. Ovcon-50 (ethinyl Warner Chilcott Co.,
estradiol and LLC, Union Street
norethindrone ) Road, 195 km 1.1,
Tablets USP, 0.05 mg/1 Fajrado, Puerto Rico
mg. 00738.
NDA 017670............. Sodium Chloride 0.45% Hospira, Inc. 275
in Plastic Container, North Field Dr., Lake
Irrigation. Forest, IL 60045.
NDA 017756............. Tylenol (acetaminophen) Johnson & Johnson
Suppositories, 120 mg Consumer Inc., McNeil
and 650 mg. Consumer Healthcare
Division, 7050 Camp
Hill Rd., Fort
Washington, PA 19034.
NDA 017748............. Noriday 1+50 (mestranol GD Searle LLC.
and norethindrone)
Tablets.
NDA 018031............. Inderide (propranolol Wyeth Pharmaceuticals
HCl and Inc.
hydrochlorothiazide)
Tablets, 40 mg/25 mg
and 80 mg/25 mg.
NDA 018039............. Loxitane IM (loxapine Actavis Laboratories
HCl) Injection, UT, Inc., Subsidiary
Equivalent to (EQ) 50 of Teva
mg base/mL. Pharmaceuticals USA,
Inc., 425 Privet
Road, Horsham, PA
19044.
NDA 018104............. Hylorel (guanadrel Pharmacia and Upjohn
sulfate) Tablets, 10 Co.
mg and 25 mg.
NDA 018239............. Propine (dipivefrin Allergan, Inc.
HCl) Ophthalmic
Solution USP, 0.1%.
NDA 018254............. Ringer's and Dextrose Hospira Inc.
5% (calcium chloride,
dextrose, potassium
chloride, sodium
chloride) Injection
USP (in Plastic
Container).
NDA 018353............. Flagyl I.V. GD Searle LLC.
(metronidazole HCl)
for Injection, EQ 500
mg base/vial.
NDA 018388............. Lidocaine HCl in Hospira, Inc.
Dextrose 5% in Plastic
Container Injection.
[[Page 28324]]
NDA 018404............. 0.25% Acetic Acid Do.
Irrigation Solution.
NDA 018406............. PhysioSol (magnesium Do.
chloride, potassium
chloride, sodium
acetate, sodium
chloride, sodium
gluconate) Irrigation
Solution.
NDA 018460............. Dialyte (Peritoneal B. Braun Medical Inc.
Dialysis Solution)
Pattern LM (calcium
chloride, dextrose,
magnesium chloride,
sodium acetate, sodium
chloride) with
Dextrose.
NDA 018465............. Soyacal (soybean oil) Grifols Biologicals
Injection, 10%. Inc., 5555 Valley
Blvd., Los Angeles,
CA 90032.
NDA 018509............. Baros (sodium Mallinckrodt Inc.
bicarbonate, tartaric
acid) Effervescent
Granules, 460 mg/g;
420 mg/g).
NDA 018713............. Mycelex (clotrimazole) Bayer Healthcare
Troche/Lozenge, 10 mg. Pharmaceuticals Inc.,
100 Bayer Blvd.,
Whippany, NJ 07981.
ANDA 018730............ Indomethacin Capsules Zenith Laboratories,
USP, 25 mg and 50 mg. Inc., 140 LeGrand
Ave., Northvale, NJ
07647.
NDA 018786............. Soyacal(Soybean Oil) Grifols Biologicals
Injection, 20%. Inc., 5555 Valley
Blvd., Los Angeles,
CA 90032.
NDA 018807............. Dialyte (Peritoneal B. Braun Medical Inc.
Dialysis Concentrates)
(calcium chloride,
dextrose, magnesium
chloride, sodium
acetate, sodium
chloride) with
Dextrose.
NDA 018887............. Intal (cromolyn sodium) King Pharmaceuticals
Metered Dose Inhaler, Inc., Subsidiary of
0.8 mg/inhalation. Pfizer Inc., 235 East
42nd St., New York,
NY 10017.
NDA 018970............. Liposyn III 20% Hospira, Inc.
(soybean oil)
Injection.
NDA 018991............. Liposyn II 20% Do.
(safflower oil and
soybean oil) Injection.
NDA 018997............. Liposyn II 10% Do.
(safflower oil and
soybean oil) Injection.
NDA 019038............. Calan (verapamil HCl) G.D. Searle LLC.
Injection, 2.5 mg/mL.
NDA 019121............. Bretylium Tosylate in B. Braun Medical Inc.
5% Dextrose Injection.
NDA 019212............. Theophylline and 5% Do.
Dextrose Injection.
NDA 019229............. Zinc Sulfate Injection, Abraxis Pharmaceutical
EQ 1 mg Zinc/mL. Products, 6133 North
River Rd., Suite 500,
Rosemont, IL 60018.
NDA 019350............. Cupric Sulfate Do.
Injection, EQ 0.4 mg
Copper/mL.
NDA 019415............. Fertinex EMD Serono, Inc., One
(urofollitropin) for Technology Pl.,
Subcutaneous Rockland, MA 02370.
Injection, 75
international units
(IU)/ampule and 150 IU/
ampule, and Metrodin
(urofollitropin) for
Intramuscular
Injection, 75 IU)/
ampule and 150 IU/
ampule.
NDA 019510............. Pepcid (famotidine) Merck Sharp & Dohme
Injection, 10 mg/mL. Corp., Subsidiary of
Merck & Co., Inc., 1
Merck Dr., P.O. Box
100, Whitehouse
Station, NJ 08889.
NDA 019514............. Ionosol T and 5% Hospira, Inc.
Dextrose Injection.
NDA 019515............. Ionosol B and 5% Do.
Dextrose Injection.
NDA 019641............. Terazol 3 (terconazole) Janssen
Vaginal Suppositories, Pharmaceuticals,
80 mg. Inc., 1000 U.S.
Highway 202, Raritan,
NJ 08869.
NDA 019643............. Mevacor (lovastatin) Merck Sharp & Dohme
Tablets, 10 mg, 20 mg, Corp.
and 40 mg.
NDA 019660............. Tilade (nedocromil King Pharmaceuticals
sodium) Metered Dose Inc.
Inhaler, 1.75 mg/
inhalation.
NDA 019793............. Pharmaseal Scrub Care CareFusion 2200, Inc.,
(chlorhexidine 75 North Fairway Dr.,
gluconate) Sponge, 4%. Vernon Hills, IL
60061.
NDA 019802............. Heparin Sodium in B. Braun Medical Inc.
Sodium Chloride
Injection.
NDA 019834............. Plendil (felodipine) AstraZeneca
Extended-Release Pharmaceuticals LP,
Tablets, 2.5 mg, 5 mg, 1800 Concord Pike,
and 10 mg. Wilmington, DE 19803.
NDA 019907............. Optipranolol Bausch & Lomb, Inc.,
(metipranolol HCl) Subsidiary of Valeant
Ophthalmic Solution, Pharmaceuticals
0.3%. International, Inc.,
400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
NDA 019933............. Lactated Ringer's Baxter Healthcare
(calcium chloride, Corp.
potassium chloride,
sodium chloride,
sodium lactate)
Irrigation Solution.
NDA 020092............. Dilacor XR (diltiazem Allergan Sales, LLC,
HCl) Extended-Release 2525 Dupont Drive,
Capsules, 120 mg, 180 Irvine, CA 92612.
mg, and 240 mg.
NDA 020146............. Nitrodisc GD Searle LLC.
(nitroglycerin)
Transdermal System,
0.2 mg/hour (hr), 0.3
mg/hr, and 0.4 mg/hr.
NDA 020181............. Liposyn III 30% Hospira, Inc.
(soybean oil)
Injection.
NDA 020249............. Pepcid Preservative Merck Sharp & Dohme
Free (famotidine) Corp.
Injection, 0.4 mg/mL.
NDA 020291............. Combivent (albuterol Boehringer Ingelheim
sulfate and Pharmaceuticals Inc.,
ipratropium bromide) 900 Ridgebury Rd.,
Metered Dose Inhaler, P.O. Box 368,
EQ 0.09 mg base/ Ridgefield, CT 06877.
inhalation; 0.018 mg/
inhalation.
NDA 020292............. FerriSeltz (ferric Otsuka Pharmaceutical
ammonium citrate) Co., Ltd., 508
Powder for Oral Carnegie Center Dr.,
Solution, 600 mg/ Princeton, NJ 08540.
packet.
ANDA 020360............ Hepatasol Sulfite-free Baxter Healthcare
(amino acids) Corp.
Injection, 8%.
NDA 020409............. Nasarel (flunisolide) Teva Branded
Nasal Spray, 0.029 mg/ Pharmaceutical
spray. Products R&D, Inc.,
74 NW 176th St.,
Miami, FL 33169.
NDA 020448............. Imodium A-D (loperamide Johnson & Johnson
HCl) Tablets Consumer Inc.
(Chewable), 2 mg.
NDA 020506............. Tiamate (diltiazem Merck & Co., Inc.,
malate) Extended- P.O. Box 1000, UG2C-
Release Tablets. 50, North Wales, PA
19454.
[[Page 28325]]
NDA 020518............. Retrovir (zidovudine) ViiV Healthcare Co.,
Tablets, 200 mg and Five Moore Dr., P.O.
300 mg. Box 13398, Research
Triangle Park, NC
27709.
NDA 020569............. Vitrasert (ganciclovir) Bausch & Lomb Inc.
Implant, 4.5 mg.
NDA 020606............. Imodium Multi-Symptom Johnson & Johnson
Relief (loperamide HCl Consumer Inc.
and simethicone)
Tablets (Chewable), 2
mg/125 mg.
NDA 020635............. Levaquin (levofloxacin) Janssen
Injection, EQ 250 mg/ Pharmaceuticals, Inc.
50 mL, EQ 500 mg/100
mL, and EQ 750 mg/150
mL.
NDA 020745............. Zantac (ranitidine HCl) Sanofi-Aventis U.S.
Tablets LLC, 55 Corporate
(Effervescent), EQ 75 Drive, Bridgewater,
mg base. NJ 08807.
NDA 020752............. Pepcid RPD (famotidine) Merck Sharp & Dohme
Orally Disintegrating Corp.
Tablets, 20 mg and 40
mg.
NDA 020799............. Floxin Otic (ofloxacin) Daiichi Sankyo Co.,
Otic Solution, 0.3%. Ltd., 399 Thornall
St., Edison, NJ
08837.
NDA 020813............. Klonopin (clonazepam) Hoffmann La-Roche,
Orally Disintegrating Inc., c/o Genentech,
Tablets, 0.125 mg, Inc., 1 DNA Way MS
0.25 mg, 0.5 mg, 1 mg, #242, South San
and 2 mg. Francisco, CA 94080.
NDA 020902............. Pepcid AC (famotidine) Johnson & Johnson
Tablets OTC, 10 mg. Consumer Inc.
NDA 021097............. Visicol (sodium Salix Pharmaceuticals
phosphate, monobasic Inc., Subsidiary of
monohydrate, and Valeant
sodium phosphate Pharmaceuticals North
dibasic anhydrous) America LLC, 400
Tablets USP. Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
NDA 021214............. Rescula (unoprostone R-Tech Ueno, Ltd., c/o
isopropyl) Ophthalmic Sucampo Pharma
Solution, 0.15%. Americas, LLC, 805
King Farm Blvd.,
Suite 550, Rockville,
MD 20850.
NDA 021224............. Razadyne (galantamine Janssen
hydrobromide) Oral Pharmaceuticals, Inc.
Solution, 4 mg/mL.
NDA 021317............. Bayer Extra Strength Bayer Healthcare LLC,
Aspirin (aspirin) 100 Bayer Blvd.,
Tablets, 500 mg. Whippany, NJ 07981.
NDA 021412............. Tovalt ODT (zolpidem Valeant
tartrate) Orally Pharmaceuticals North
Disintegrating America, LLC, 400
Tablets, 5 mg and 10 Somerset Corporate
mg. Blvd., Bridgewater,
NJ 08807.
NDA 021453............. Zerit XR (stavudine) Bristol-Myers Squibb
Extended-Release Co., 5 Research
Capsules, 37.5 mg, 50 Parkway, Wallingford,
mg, 75 mg, and 100 mg. CT 06492.
NDA 021483............. Geodon (ziprasidone Pfizer Inc., 235 East
HCl) Oral Suspension, 42nd St., New York,
EQ10 mg base/mL. NY 10017.
NDA 021494............. Axid (nizatidine) Oral Braintree
Solution, 15 mg/mL. Laboratories, Inc.,
60 Columbian St.
West, P.O. Box
850929, Braintree, MA
02185.
NDA 021589............. Kemstro (baclofen) UCB, Inc.,1950 Lake
Orally Disintegrating Park Dr., Smyrna, GA
Tablets, 10 mg and 20 30080.
mg.
NDA 021595............. Sanctura (trospium Allergan, Inc.
chloride) Tablets, 20
mg.
NDA 021721............. Levaquin (levofloxacin) Janssen
Oral Solution, 25 mg/ Pharmaceuticals, Inc.
mL.
NDA 021763............. Citalopram Hydrobromide Valeant International
Orally Disintegrating (Barbados) SRL
Tablets, EQ 10 mg Welches, Christ
base, EQ 20 mg base, Church, Barbados,
and EQ 40 mg base. BB17154.
NDA 021864............. Lybrel (ethinyl Wyeth Pharmaceuticals
estradiol and Inc.
levonorgestrel)
Tablets, 0.02 mg/0.09
mg.
NDA 022103............. Sanctura XR (trospium Allergan, Inc.
chloride) Extended-
Release Capsules, 60
mg.
NDA 022220............. Trivaris (triamcinolone Do.
acetonide) Injectable
Suspension, 80 mg/mL.
NDA 022294............. Zidovudine Tablets, 60 Aurobindo Pharma
mg. Limited, c/o
Aurobindo Pharma USA,
Inc., 2400 Route 130
North, Dayton, NJ
08810.
NDA 022377............. Alsuma (sumatriptan Meridian Medical
succinate) Auto- Technologies, Inc.,
Injector, EQ 6 mg base/ 1945 Craig Rd., St.
0.5 mL Injectable. Louis, MO 63146.
NDA 022411............. Oleptro (trazodone HCl) Angelini Pharma Inc.,
Extended-Release 8322 Helgerman Ct.,
Tablets, 150 mg and Gaithersburg, MD
300 mg. 20877.
NDA 022494............. Sodium Fluoride F 18 National Institutes of
Injection, 10-200 mCi/ Health/National
mL. Cancer Institute,
Cancer Imaging
Program, 9609 Medical
Center Dr., Room 4-
W236, MSC 9729,
Bethesda, MD 20892-
9729.
NDA 022545............. Tekamlo (aliskiren Novartis
hemifumarate and Pharmaceuticals
amlodipine besylate) Corp., One Health
Tablets. Plaza, East Hanover,
NJ 07936.
ANDA 040032............ Cyclophosphamide Roxane Laboratories,
Tablets USP, 25 mg and Inc., 1809 Wilson
50 mg. Rd., Columbus, OH
43228.
ANDA 040262............ Leucovorin Calcium for Pharmachemie B.V., c/o
Injection, EQ 350 mg SICOR
base/vial. Pharmaceuticals,
Inc., 19 Hughes,
Irvine, CA 92618.
ANDA 040772............ Fluorouracil Injection Sandoz Inc., 100
USP, 50 mg/mL. College Road West,
Princeton, NJ 08540.
ANDA 040793............ A-Methapred Hospira, Inc.
(methylprednisolone
sodium succinate) for
Injection USP, EQ 40
mg base/vial.
ANDA 040827............ A-Methapred Do.
(methylprednisolone
sodium succinate) for
Injection USP, EQ 125
mg base/vial.
NDA 050182............. Erythrocin Do.
(erythromycin
lactobionate) for
Injection USP.
NDA 050435............. Geocillin Pfizer, Inc.
(carbenicillin indanyl
sodium) Tablets, EQ
382 mg base.
NDA 050528............. Duricef (cefadroxil) Warner Chilcott Co.,
Tablets USP, EQ 1 g Inc., 100 Enterprise
base. Drive, Rockaway, NJ
07866.
NDA 050545............. Pipracil (piperacillin Wyeth Pharmaceuticals
sodium) Injection. Inc.
NDA 050590............. Timentin (ticarcillin GlaxoSmithKline.
disodium and
clavulanate potassium)
for Injection.
[[Page 28326]]
NDA 050658............. Timentin Galaxy Plastic Do.
Container(ticarcillin
disodium and
clavulanate potassium)
for Injection.
NDA 050664............. Cefzil (cefprozil) Corden Pharma Latina,
Tablets, 250 mg and S.p.A. , c/o
500 mg. Clinipace, Inc., 4840
Pearl East Circle,
Suite 210E, Boulder,
CO 80301.
NDA 050665............. Cefzil (cefprozil) Oral Do.
Suspension, 125 mg/5
mL and 250 mg/5 mL.
ANDA 060076............ Streptomycin Sulfate Pfizer Inc.
Powder for Injection,
EQ 1 g base/vial and
EQ 5 g base/vial.
ANDA 060111............ Streptomycin Sulfate Do.
Powder for Injection,
EQ 1 g base/2.5 mL.
ANDA 060607............ Neomycin Sulfate Lannett Co., Inc.,
Tablets, 500 mg. 9000 State Rd.,
Philadelphia, PA
19136.
ANDA 061578............ Poly-Rx (polymyxin B X-GEN Pharmaceuticals,
sulfate USP) for Inc., 300 Daniel
Prescription Zenker Dr.,
Compounding. Horseheads, NY 14845.
ANDA 061580............ Baci-Rx (bacitracinUSP) Do.
for Prescription
Compounding.
ANDA 061645............ Econochlor Alcon Laboratories,
(chloramphenicol) Inc., 6201 South
Ophthalmic Solution Freeway, TC-45, Fort
USP, 0.5%. Worth, TX 76134-2099.
ANDA 061648............ Chloramphenicol Do.
Ophthalmic Ointment,
1%.
ANDA 062118............ Cephalexin Capsules Do.
USP, EQ 250 mg base
and EQ 500 mg base.
ANDA 062206............ Cefaclor for Oral Do.
Suspension USP, EQ 125
mg base/5 mL, EQ 187
mg base/5 mL, EQ 250
mg base/5 mL, and EQ
375 mg base/5 mL.
ANDA 062339............ Statrol (neomycin Alcon Laboratories,
sulfate and polymyxin Inc.
B sulfate) Ophthalmic
Solution, EQ 3.5 mg
base/mL and 16,250
units/mL.
ANDA 062523............ Gentamicin Sulfate Do.
Ophthalmic Solution
USP, EQ 0.3% base.
ANDA 062628............ Chloramphenicol Do.
Ophthalmic Solution
USP, 0.5%.
ANDA 062691............ Timentin ADD-Vantage GlaxoSmithKline.
(ticarcillin disodium
and clavulanate
potassium) for
Injection USP, EQ 3 g
base/vial and EQ 100
mg base/vial.
ANDA 062714............ Neomycin Sulfate and Alcon Pharmaceuticals
Dexamethasone Sodium Ltd., 6201 South
Phosphate Ophthalmic Freeway, Fort Worth,
Solution, EQ 3.5 mg TX 76134.
base/mL and EQ 0.1%
and.
ANDA 062721............ Neomycin and Polymyxin Do.
B Sulfate and
Dexamethasone
Ophthalmic Suspension
USP, EQ 3.5 mg base/
mL; 10,000 units/mL;
0.1%.
ANDA 062822............ Pediotic (neomycin Monarch
sulfate and polymyxin Pharmaceuticals,
B sulfate and Inc., Subsidiary of
hydrocortisone) Otic Pfizer Inc., 235 East
Suspension USP. 42nd St., New York,
NY 10017-7555.
ANDA 063176............ Tobramycin Ophthalmic Alcon Pharmaceuticals,
Solution USP, 0.3%. Ltd.
ANDA 063208............ Cefazolin for Injection Steri-Pharma, LLC, 429
USP, EQ 1 g base/100 South West St.,
mL vial. Syracuse, NY 13202.
ANDA 063216............ Cefazolin for Injection Do.
USP, EQ 500 mg base/
100 mL vial.
ANDA 063283............ Amikacin Sulfate Hospira, Inc.
Injection, EQ 62.5 mg
base/mL.
ANDA 064169............ Cefazolin for Injection Fresenius Kabi USA,
USP, EQ 500 mg base/ LLC, Three Corporate
vial and EQ 1 g base/ Dr., Lake Zurich, IL
vial. 60047.
ANDA 064170............ Cefazolin for Injection Do.
USP, EQ 10 g base/vial
and EQ 20 g base/vial.
ANDA 065010............ Neo-Fradin (neomycin X-GEN Pharmaceuticals,
sulfate) Oral Solution Inc.
USP, EQ 87.5 mg base/5
mL.
ANDA 065011............ Cefoxitin (cefoxitin Fresenius Kabi USA,
sodium) for Injection, LLC.
EQ 10 g base/Vial.
ANDA 065012............ Cefoxitin for Injection Do.
USP, EQ 1 g base/vial
and EQ 2 g base/vial.
ANDA 065245............ Ceftriaxone for Do.
Injection USP, EQ 250
mg base/vial, EQ 500
mg base/vial, EQ 1 g
base/vial, and EQ 2 g
base/vial.
ANDA 065252............ Ceftriaxone for Do.
Injection, EQ 10 g
base/vial.
ANDA 065324............ Amoxicillin Tablets for Aurobindo Pharma
Oral Suspension USP, Limited.
200 mg and 400 mg.
ANDA 065339............ Epirubicin HCl Sandoz, Inc.
Injection, 50 mg/25 mL
and 200 mg/100 mL.
ANDA 065465............ Ceftriaxone for Bedford Laboratories,
Injection USP, EQ 250 c/o PAREXEL
mg base/vial, EQ 500 International, 4600
mg base/vial, EQ 1 g East-West Highway,
base/vial, and EQ 2 g Suite 350, Bethesda,
base/vial. MD 20814.
ANDA 065475............ Ceftriaxone for Do.
Injection USP, EQ 10 g
base/vial.
ANDA 070088............ Ibuprofen Tablets USP, BASF Corp., 5738
600 mg. County Rd. 4, Bishop,
TX 78343.
ANDA 070187............ Disopyramide Phosphate Ivax Pharmaceuticals
Capsules USP, EQ 150 Inc., Subsidiary of
mg base. Teva Pharmaceuticals
USA, Inc., 425 Privet
Road, Horsham, PA
19044.
ANDA 070587............ Bupivacaine HCl Hospira, Inc.
Injection USP, 0.75%.
ANDA 070659............ Clonidine HCl Tablets, Teva Pharmaceuticals
0.3 mg. USA Inc., 1090
Horsham Rd., P.O. Box
1090, North Wales, PA
19454.
ANDA 070702............ Clonidine HCl Tablets, Do.
0.2 mg.
ANDA 070747............ Clonidine HCl Tablets, Do.
0.1 mg.
ANDA 070804............ Metaproterenol Sulfate Mylan Specialty, L.P.,
Inhalation Solution 781 Chestnut Ridge
USP, 0.6%. Rd., P.O. Box 4310,
Morgantown, WV 26504.
ANDA 071067............ Methyldopa Tablets USP, Teva Pharmaceuticals
500 mg. USA, Inc.
[[Page 28327]]
ANDA 071101............ Clonidine HCl Tablets Duramed
USP, 0.3 mg. Pharmaceuticals,
Inc., 2 Quaker Rd.,
P.O. Box 2900,
Pomona, NY 10970.
ANDA 071102............ Clonidine HCl Tablets Do.
USP, 0.2 mg.
ANDA 071103............ Clonidine HCl Tablets Do.
USP, 0.1 mg.
ANDA 071105............ Methyldopa Tablets USP, Teva Pharmaceuticals
125 mg. USA, Inc.
ANDA 071106............ Methyldopa Tablets USP, Do.
250 mg.
ANDA 071426............ Vincasar PFS Teva Parenteral
(vincristine sulfate) Medicines Inc., 19
Injection USP, 1 mg/mL. Hughes, Irvine, CA
92618.
ANDA 071584............ Diazepam Injection USP, Hospira, Inc.
5 mg/mL.
ANDA 071786............ Metaproterenol Sulfate Mylan Specialty L.P.
Inhalation Solution
USP, 0.4%.
ANDA 072323............ Acetylcysteine Solution Roxane Laboratories,
USP, 10%. Inc.
ANDA 072324............ Acetylcysteine Solution Do.
USP, 20%.
ANDA 073034............ Metaproterenol Sulfate G&W Laboratories Inc.,
Oral Solution USP, 10 111 Coolidge St.,
mg/5 mL. South Plainfield, NJ
07080.
ANDA 073636............ Dipivefrin HCl Alcon Pharmaceuticals,
Ophthalmic Solution Ltd.
USP, 0.1%.
ANDA 073676............ Atenolol Tablets, 50 mg GD Searle LLC.
and 100 mg.
ANDA 074023............ Ranitidine Tablets USP, Mylan Pharmaceuticals
150 mg and 300 mg. Inc.
ANDA 074160............ Bumetanide Injection Hospira, Inc.
USP, 0.25 mg/mL.
ANDA 074269............ Cimetidine in Sodium Do.
Chloride 0.9%
Injection USP, EQ6 mg
base/mL).
ANDA 074300............ Lorazepam Injection Do.
USP, 2 mg/mL and 4 mg/
mL.
ANDA 074396............ Enflurane Inhalation , Piramal Critical Care,
99.9%. Inc., 3950 Schelden
Circle, Bethlehem, PA
18017.
ANDA 074546............ Clozapine Tablets USP, Sandoz, Inc.
25 mg and 100 mg.
ANDA 074632............ Atracurium Besylate Hospira, Inc.
Injection, 10 mg/mL.
ANDA 074851............ Levobunolol HCl Alcon Laboratories,
Ophthalmic Solution Inc.
USP, 0.25%.
ANDA 074927............ Etodolac Tablets USP, Lehigh Valley
400 mg. Technologies, Inc.,
514 North 12th St.,
Allentown, PA 18102.
ANDA 075117............ Orapred (prednisolone Concordia
sodium phosphate) Oral Pharmaceuticals,
Solution, EQ 15 mg Inc., c/o Mapi USA,
base/5 mL. Inc., 2343 Alexandria
Dr., Suite 100,
Lexington, KY 40504.
ANDA 075436............ Paclitaxel Injection Accord Healthcare
USP, 6 mg/mL. Inc., 1009 Slater
Rd., Suite 210-B,
Durham, NC 27703.
ANDA 075721............ Leuprolide Acetate Genzyme Corp., 500
Injection, 1 mg/0.2 mL. Kendall St.,
Cambridge, MA 02142.
ANDA 075963............ Tramadol HCl Tablets, Ivax Pharmaceuticals
50 mg. Inc.
ANDA 076234............ Flavoxate HCl Tablets, Impax Laboratories,
100 mg. Inc., 30831 Huntwood
Ave., Hayward, CA
94544.
ANDA 076296............ Vincristine Sulfate Fresenius Kabi USA,
Injection USP, 1 mg/mL. LLC.
ANDA 076394............ Amiodarone HCl Par Sterile Products,
Injection, 50 mg/mL. LLC, Morris Corporate
Center 2, One Upper
Pond Rd., Parsippany,
NJ 07054.
ANDA 076401............ Vincristine Sulfate Fresenius Kabi USA,
Injection USP, 1 mg/mL. LLC.
ANDA 076414............ Milrinone Lactate in 5% B. Braun Medical Inc.
Dextrose Injection, EQ
20 mg base/100 mL.
ANDA 076563............ Diltiazem HCl Extended- Nesher Pharmaceuticals
Release Capsules USP, (USA) LLC, 13910 St.
120 mg, 180 mg, 240 Charles Rock Rd.,
mg, 300 mg, 360 mg, Bridgeton, MO 63044.
420 mg.
ANDA 076699............ Parcopa (carbidopa and UCB, Inc., 1950 Lake
levodopa) Orally Park Dr., Bldg. 2100,
Disintegrating Smyrna, GA 30080.
Tablets, 10 mg/100 mg,
25 mg/100 mg, and 25
mg/250 mg.
ANDA 077275............ Didanosine Tablets for Aurobindo Pharma
Oral Suspension USP, Limited.
100 mg, 150 mg, and
200 mg.
ANDA 077774............ Stavudine for Oral Do.
Solution USP, 1 mg/mL.
ANDA 077887............ Carvedilol Tablets USP, Hikma Pharmaceuticals,
3.125 mg, 6.25 mg, c/o West-Ward
12.5 mg, 25 mg. Pharmaceuticals
Corp., 401 Industrial
Way West, Eatontown,
NJ 07724.
ANDA 077968............ Alprazolam Extended- Impax Laboratories,
Release Tablets, 0.5 Inc.
mg, 1 mg, 2 mg, and 3
mg.
ANDA 077996............ Alprazolam Extended- Do.
Release Tablets, 0.5
mg, 1 mg, 2 mg, 3 mg.
ANDA 078112............ Didanosine for Oral Aurobindo Pharma
Solution USP, 10 mg/mL. Limited.
ANDA 078240............ Carvedilol Tablets, Pliva Hrvatska d.o.o.,
3.125 mg, 6.25 mg, Subsidiary of Teva
12.5 mg, and 25 mg. Pharmaceutical
Industries Ltd., 425
Privet Rd., Horsham,
PA 19044.
ANDA 078254............ Atenolol Tablets USP, Northstar Healthcare
25 mg, 50 mg, and 100 Holdings, c/o Quality
mg. Regulatory
Consultants, 1966
Anglers Cove, Vero
Beach, FL 32963.
ANDA 078285............ Bicalutamide Tablets Roxane Laboratories,
USP, 50 mg. Inc.
ANDA 078298............ Sumatriptan Succinate Hikma Pharmaceuticals.
Tablets USP, EQ 25 mg
base, EQ 50 mg base,
EQ 100 mg base.
ANDA 078310............ Lamotrigine Tablets Pharmascience Inc., c/
USP, 25 mg, 100 mg, o Pharmascience
150 mg, and 200 mg. Laboratories Inc.,
295 Firetower Rd.,
Tonawanda, NY 14150.
ANDA 078334............ Granisol (granisetron PediatRx, Inc., c/o
HCl Oral Solution, 2 Cardinal Health
mg base/10mL. Regulatory Sciences,
7400 West 110th St.,
Commerce Plaza II,
Suite 300, Overland
Park, KS 66210.
ANDA 078374............ Metoclopramide Tablets Northstar Healthcare
USP, EQ 5 mg base and Holdings.
EQ 10 mg base.
ANDA 078408............ Vinorelbine Injection Sandoz Inc.
USP, EQ 10 mg base/mL.
[[Page 28328]]
ANDA 078501............ Dronabinol Capsules Insys Therapeutics,
USP, 2.5 mg, 5 mg, and Inc., 1333 South
10 mg. Spectrum Blvd., Suite
100, Chandler, AZ
85286.
ANDA 078577............ Levofloxacin Injection, Hospira Inc.
EQ 750 mg/30 mL and EQ
500 mg/20 mL.
ANDA 078782............ Gabapentin Tablets USP, Hikma Pharmaceuticals.
600 mg and 800 mg.
ANDA 078808............ Granisetron HCl Sandoz Inc.
Injection USP, EQ 0.1
mg base/mL.
ANDA 078812............ Oxaliplatin Injection Do.
USP, 50 mg/10 mL and
100 mg/20 mL.
ANDA 078952............ Glimepiride Tablets Hikma Pharmaceuticals.
USP, 1 mg, 2 mg, and 4
mg.
ANDA 079033............ Fomepizole Injection, Mylan Institutional
1.5 g/1.5 mL. LLC, 4901 Hiawatha
Dr., Rockford, IL
61103.
ANDA 080020............ Isopto Cetamide Alcon Laboratories,
(sulfacetamide sodium) Inc.
Ophthalmic Solution,
15%.
ANDA 080021............ Sulfacetamide Sodium Do.
Ophthalmic Ointment,
10%.
ANDA 080229............ Naphcon Forte Do.
(naphazoline HCl)
Ophthalmic Solution
USP 0.1%.
ANDA 080248............ Albalon (naphazoline Allergan, Inc.
HCl) Ophthalmic
Solution USP, 0.1%.
ANDA 080472............ Hytone (hydrocortisone) Valeant International
Cream, 1% and 2.5%. (Barbados) SRL, c/o
Valeant
Pharmaceuticals North
America LLC, 400
Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
ANDA 080473............ Hytone (hydrocortisone) Do.
Lotion, 1% and 2.5%.
ANDA 081043............ Prednisolone Sodium Alcon Pharmaceuticals,
Phosphate Ophthalmic Ltd.
Solution USP, EQ 0.11%
phosphate.
ANDA 081044............ Prednisolone Sodium Do.
Phosphate Ophthalmic
Solution USP, EQ 0.9%
phosphate.
ANDA 083205............ Orabase HCA Colgate-Palmolive Co.,
(hydrocortisone 909 River Rd., P.O.
acetate) Topical Box 1343, Piscataway,
Paste, 0.5%. NJ 08855-1343.
ANDA 083342............ Maxidex (dexamethasone Alcon Laboratories,
sodium phosphate) Inc.
Ophthalmic Ointment,
EQ 0.05% phosphate.
ANDA 084645............ Chlordiazepoxide HCl Upsher-Smith
Capsules USP, 25 mg. Laboratories, Inc.
ANDA 084927............ Methocarbamol Tablets Impax Laboratories,
USP, 500 mg. Inc.
ANDA 084928............ Methocarbamol Tablets Do.
USP, 750 mg.
ANDA 085000............ Chlordiazepoxide HCl Hikma Pharmaceuticals.
Capsules USP, 10 mg.
ANDA 085014............ Chlordiazepoxide HCl Do.
Capsules USP, 5 mg.
ANDA 085095............ Statobex-G Teva Pharmaceuticals
(phendimetrazine USA, Inc.
tartrate) Tablets, 35
mg.
ANDA 085294............ Chlordiazepoxide HCl Hikma Pharmaceuticals.
Capsules USP, 25 mg.
ANDA 085380............ Butisol Sodium Meda Pharmaceuticals
(butabarbital sodium) Inc., 265 Davidson
Oral Solution USP, 30 Ave., Suite #4300,
mg/5 mL. Somerset, NJ 08873.
ANDA 085734............ Ammonium Chloride B. Braun Medical Inc.
Injection USP, 40 mEQ/
100 mL.
ANDA 085981............ Hydrocortisone Acetate X-Gen Pharmaceuticals,
USP Micronized for Inc.
Prescription
Compounding, 100%.
ANDA 085982............ Hydro-Rx Do.
(hydrocortisone) USP
Micronized for
Prescription
Compounding, 100%.
ANDA 085995............ Pediatric LTA Kit Hospira, Inc.
(lidocaine HCl)
Topical Solution USP,
2%.
ANDA 086535............ Acticort Baker Norton
(hydrocortisone) Pharmaceuticals Inc.,
Lotion USP, 1%. 8800 N.W. 36 St.,
Miami, FL 33178-2404.
ANDA 086911............ Phentermine HCl Teva Pharmaceuticals
Capsules USP, 30 mg. USA, Inc.
ANDA 087547............ Isopto Cetapred Alcon Laboratories,
(sulfacetamide sodium Inc.
and prednisolone
acetate) Ophthalmic
Ointment USP, 10%/
0.25%.
ANDA 087771............ Cetapred (sulfacetamide Do.
sodium and
prednisolone acetate)
Ophthalmic Ointment
USP, 10%/0.25%.
ANDA 087907............ Epinephrine Inhalation Armstrong
Aerosol USP, 0.2 mg/ Pharmaceuticals,
inhalation). Inc., 25 John Rd.,
Canton MA 02021.
ANDA 088613............ Phentermine HCl Teva Pharmaceuticals
Capsules USP, 30 mg. USA, Inc.
ANDA 088614............ Phentermine HCl Do.
Capsules USP, 30 mg.
ANDA 088630............ Pseudoephedrine HCl and Do.
Triprolidine HCl
Tablets, 60 mg/2.5 mg.
ANDA 088631............ Butabarbital Sodium Do.
Tablets, 30 mg.
ANDA 088632............ Butabarbital Sodium Do.
Tablets, 15 mg.
ANDA 088797............ Phentermine HCl USL Pharma Inc., 301
Capsules USP, 30 mg. South Cherokee St.,
Denver, CO 80223
ANDA 088910............ Phentermine HCl Tablets Do.
USP, 37.5 mg.
ANDA 088917............ Phentermine HCl Tablets Do.
USP, 37.5.
ANDA 088999............ Dipyridamole Tablets Glenmark Generics
USP, 25 mg. Limited, c/o Glenmark
Generics Inc., USA,
750 Corporate Dr.,
Mahwah, NJ 07430.
ANDA 089000............ Dipyridamole Tablets Do.
USP, 50 mg.
ANDA 089001............ Dipyridamole Tablets Do.
USP, 75 mg.
ANDA 089068............ Sulfacetamide Sodium Alcon Pharmaceuticals,
Ophthalmic Solution, Ltd.
30%.
ANDA 089172............ Tropicamide Ophthalmic Do.
Solution, 1%.
ANDA 089422............ Imipramine HCl Tablets Par Pharmaceutical
USP, 10 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 089440............ Hydrocortisone Acetate Vintage
and Pramoxine HCl Pharmaceuticals, 150
Topical Aerosol, 1%/1%. Vintage Dr.,
Huntsville, AL 35811.
[[Page 28329]]
ANDA 089497............ Imipramine HCl Tablets Par Pharmaceutical
USP, 25 mg. Inc.
ANDA 089628............ Leucovorin Calcium for Pharmachemie USA Inc.,
Injection, EQ 50 mg 323 Davis St.,
base/vial. Northborough, MA
01532.
ANDA 089681............ Bromfed-DM Wockhardt Bio AG, c/o
(brompheniramine Morton Grove
maleate, Pharmaceuticals,
dextromethorphan Inc., 6451 Main St.,
hydrobromide, and Morton Grove, IL
pseudoephedrine HCl) 60053.
Syrup, 2 mg/5 mL; 10mg/
5 mL; 30mg/5 mL.
ANDA 089915............ Leucovorin Calcium for Pharmachemie USA Inc.
Injection, EQ 100 mg
base/vial.
ANDA 090098............ Tretinoin Cream USP, Allergan Sales, LLC.
0.0375%.
ANDA 090137............ Irinotecan HCl Sandoz Inc.
Injection, 40 mg/2 mL
and 100 mg/5 mL.
ANDA 090190............ Pramipexole Do.
Dihydrochloride
Tablets, 0.125 mg,
0.25 mg, 0.5 mg, 0.75
mg, 1 mg, and 1.5 mg.
ANDA 090220............ Adenosine Injection Wockhardt Limited, c/o
USP, 3 mg/mL. Wockhardt USA LLC, 20
Waterview Blvd., 3rd
Floor, Parsippany, NJ
07054.
ANDA 090300............ Children's Cetirizine Cypress
HCl Allergy and Hives Pharmaceutical, Inc.,
Relief Oral Solution 10 North Park Place,
OTC, 5 mg/5 mL. Suite 210,
Morristown, NJ 07960.
ANDA 090751............ Cetirizine HCl Oral Aurobindo Pharma
Solution USP, 5 mg/5 Limited.
mL.
ANDA 090985............ Octreotide Acetate Wockhardt Limited.
Preservative Free
Injection EQ 0.05 mg
base/mL, EQ 0.1 mg
base/mL, and EQ 0.5 mg
base/mL.
ANDA 090986............ Octreotide Acetate Do.
Injection EQ 0.2 mg
base/mL and EQ 1 mg
base/mL.
ANDA 091068............ Ceftriaxone for Agila Specialties
Injection USP, EQ 10 g Private Limited, c/o
base/vial. Agila Specialties
Inc., 201 South Main
St., Suite 3,
Lambertville, NJ
08530.
ANDA 091185............ Topiramate Tablets USP, Hikma Pharmaceuticals.
25 mg, 50 mg, 100 mg,
and 200 mg.
ANDA 091293............ Idarubicin HCl Sandoz Inc.
Injection, 1 mg/mL.
ANDA 091299............ Fluorouracil Injection Do.
USP, 2.5 g/50 mL and 5
g/100 mL.
NDA 200045............. Amturnide (aliskiren Novartis
hemifumarate, Pharmaceuticals Corp.
amlodipine,
andhydrochlorothiazide
) Tablets.
ANDA 200146............ Doxorubicin HCl Sandoz Inc.
Injection USP, 2 mg/mL.
NDA 200199............. Topotecan Injection, EQ Do.
1 mg base/mL, EQ 3 mg
base/3 mL, and EQ 4 mg
base/4 mL.
ANDA 201211............ Bromfenac Sodium Coastal
Ophthalmic Solution, Pharmaceuticals, 1240
EQ 0.09% acid. Sugg Parkway,
Greenville, NC 27834.
NDA 201917............. Incivek (telaprevir) Vertex
Tablets, 375 mg. Pharmaceuticals,
Inc., 50 Northern
Ave., Boston, MA
02210.
NDA 202088............. Suprenza (phentermine Citius
HCl) Orally Pharmaceuticals, LLC,
Disintegrating 11 Commerce Dr.,
Tablets, 15 mg, 30 mg, First Floor,
and 37.5 mg. Cranford, NJ 07016.
ANDA 202209............ Tretinoin Cream USP, Allergan Sales, LLC.
0.075%.
NDA 202513............. Gelnique (oxybutynin) Do.
Gel, 3%.
NDA 203595............. Suclear (magnesium Braintree
sufate, polyethylene Laboratories, Inc.
glycol 3350, potassium
chloride, potassium
sulfate, sodium
bicarbonate, sodium
chloride, and sodium
sulfate) Oral Solution.
NDA 204508............. Clinolipid 20% (olive Baxter Healthcare
oil and soybean oil) Corp.
USP, 16%/4%.
NDA 206510............. Dutrebis (lamivudine Merck Sharp & Dohme
and raltegravir Corp.
potassium) Tablets,
150 mg/EQ 300 mg base.
------------------------------------------------------------------------
Therefore, under authority delegated to the Director, Center for
Drug Evaluation and Research, by the Commissioner, approval of the
applications listed in table 1, and all amendments and supplements
thereto, is hereby withdrawn. Introduction or delivery for introduction
into interstate commerce of products without approved new drug
applications violates section 301(a) and (d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are
listed in table 1 that are in inventory on the date that this notice
becomes effective (see the DATES section) may continue to be dispensed
until the inventories have been depleted or the drug products have
reached their expiration dates or otherwise become violative, whichever
occurs first.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12908 Filed 6-20-17; 8:45 am]
BILLING CODE 4164-01-P
