Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications, 61426-61430 [2015-25922]
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61426
Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
Desk Officer for the Administration for
Children and Families.
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 67 new drug applications
(NDAs) and 128 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withdrawn.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:
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–25924 Filed 10–9–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3432]
DATES:
Organon USA Inc. et al.; Withdrawal of
Approval of 67 New Drug Applications
and 128 Abbreviated New Drug
Applications
AGENCY:
ACTION:
Food and Drug Administration,
HHS.
Effective Date: November 12,
2015.
FOR FURTHER INFORMATION CONTACT:
Silver Spring, MD 20993–0002, 301–
796–3601.
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.
SUPPLEMENTARY INFORMATION:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
TABLE 1
Application No.
Drug
Applicant
NDA 001104 ............
Doca (desoxycorticosterone acetate) Injection, 5 milligrams
(mg)/milliliter (mL).
Alcohol in Dextrose Injection USP, 10 mL/100 mL and 5
grams (g)/100 mL.
Hyprotigen (modified protein hydrolysate) Injection, 5% ......
Ureaphil (urea) for Injection, 40 g/vial ...................................
Oratrol (dichlorphenamide) Tablets, 50 mg ..........................
Organon USA Inc., Subsidiary of Merck Sharp & Dohme
Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA
18109.
Do.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
Alcon Laboratories Inc., 6201 South Freeway, P.O. Box
1959, Fort Worth, TX 76134.
G.D. Searle, LLC, 235 East 42nd St., New York, NY
10017.
Shire Development Inc., 725 Chesterbrook Blvd., Wayne,
PA 19087–5637.
B. Braun Medical Inc.
Do.
Merck Sharp & Dohme Corp., 1 Merck Drive, P.O. Box
100, Whitehouse Station, NJ 08889.
Do.
Baxter Healthcare Corp. 32650 N. Wilson Rd., Round
Lake, IL 60073.
Do.
Do.
Do.
Do.
B. Braun Medical Inc.
Hospira, Inc.
Do.
Merck Sharp & Dohme Corp.
Hospira, Inc.
B. Braun Medical Inc.
MSD Consumer Care, Inc., 556 Morris Ave., Summit, NJ
07901.
Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA
19044.
B. Braun Medical Inc.
Do.
NDA 004589 ............
NDA 006170 ............
NDA 012154 ............
NDA 012449 ............
NDA 012699 ............
NDA 012892 ............
Lomotil (atropine sulfate and diphenoxylate hydrochloride
(HCl)) Solution 0.025 mg/5 mL and 2.5 mg/5 mL.
Uracil Mustard Capsule .........................................................
NDA 014738 ............
NDA 016080 ............
NDA 016096 ............
Mannitol Injection USP, 20% .................................................
Mannitol Injection USP ..........................................................
Mintezol (thiabendazole) Tablets ..........................................
NDA 016097 ............
NDA 016695 ............
Mintezol (thiabendazole) Oral Suspension ...........................
Dextrose Injection, 5% (in Ringer’s) ......................................
NDA
NDA
NDA
NDA
NDA
NDA
NDA
NDA
NDA
NDA
NDA
Plasma-Lyte M and Dextrose 5% Injection ...........................
Plasma-Lyte R Injection ........................................................
Plasma Lyte 148 and Dextrose 5% Injection ........................
Travasol (amino acids) Injection, 10% ..................................
Dextrose 5% Injection (in lactated Ringer’s) .........................
Sorbitol-Mannitol Irrigation, 2.7 g/100 mL–540 mg/100 mL ..
Serile Urea Injection ..............................................................
Clinoril (sulindac) Tablets, 150 mg and 200 mg ...................
Novamine (amino acids) Injection .........................................
Dextrose Injection USP, 60% ................................................
Drixoral Non-Drowsy (pseudoephedrine sulfate) ExtendedRelease Tablets, 120 mg.
Sulfamethoxazole and Trimethorim Tablets USP .................
017390
017438
017451
017493
017510
017636
017698
017911
017957
017995
018191
............
............
............
............
............
............
............
............
............
............
............
NDA 018242 ............
NDA 018307 ............
mstockstill on DSK4VPTVN1PROD with NOTICES
NDA 018258 ............
NDA 018268 ............
Dextrose Injection 5% (in acetated Ringer’s) ........................
Dextrose, Sodium Chloride, and Potassium Chloride Injection USP, 5%.
Thyro-Block (potassium iodide tablets USP) ........................
NDA
NDA
NDA
NDA
NDA
............
............
............
............
............
Thyro-Block (potassium iodide solution), 21 mg ...................
Calderol (calcifediol) Capsules ..............................................
Dextrose and Sodium Chloride Injection, 2.5%/0.9% ...........
Nitroglycerin Injection USP, 5 mg/mL ...................................
Nizoral (ketoconazole) Tablets, 200 mg ...............................
NDA 018684 ............
NDA 018722 ............
NDA 018725 ............
Branchamin (amino acids) Injection, 4% ...............................
Sodium Chloride 0.9%, and Potassium Chloride Injection ...
Acetated Ringer’s Injection ....................................................
018308
018312
018376
018531
018533
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Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400,
Somerset, NJ 08873.
Do.
Organon USA Inc., Subsidiary of Merck & Co., Inc.
B. Braun Medical Inc.
Hospira, Inc.
Janssen Pharmaceuticals, Inc., c/o Janssen Research &
Development, LLC, 920 Route 202 South, P.O. Box 300,
Raritan, NJ 08869–0602.
Baxter Healthcare Corp.
B. Braun Medical Inc.
Do.
E:\FR\FM\13OCN1.SGM
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
61427
TABLE 1—Continued
Application No.
Drug
Applicant
NDA 018744 ............
NDA 018818 ............
Dextrose and Potassium Chloride Injection ..........................
Metronidazole Tablets USP, 250 mg and 500 mg ................
NDA 018840 ............
NDA 019037 ............
Dextrose 5%, and Electrolyte No. 75 Injection .....................
Imodium (loperamide HCl) Oral Solution, 1 mg/5 mL ...........
NDA 019047 ............
NDA 019439 ............
Plasma-Lyte 56 (electrolyte solution) Injection .....................
K-Dur (potassium chloride) Extended-Release Tablets, 10
milliequivalents (mEq) and 20 mEq.
Toradol (ketorolac tromethamine) Tablets, 10 mg ................
Do.
Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
Baxter Healthcare Corp.
Janssen Pharmaceuticals, Inc., c/o Janssen Research &
Development, LLC, 1125 Trenton-Harbourton Rd., P.O.
Box 200, Titusville, NJ 08560.
Baxter Healthcare Corp.
Merck Sharp & Dohme Corp.
NDA 019645 ............
NDA 019681 ............
NDA 019682 ............
NDA 019683 ............
NDA 019718 ............
NDA 019778 ............
NDA
NDA
NDA
NDA
NDA
019843
019864
019867
020004
020173
............
............
............
............
............
NDA 020177 ............
NDA 020536 ............
NDA 020004 ............
NDA 020173 ............
Aminosyn II in Dextrose Injection ..........................................
Aminosyn II with Electrolytes and Adjusted Phosphate in
Dextrose Injection.
Aminosyn II with Electrolytes in Dextrose with Calcium Injection.
Isolyte E (multi-electrolyte) Injection .....................................
Prinzide (lisinopril and hydrochlorothiazide) Tablets, 10 mg/
12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg.
Isolyte S (multi-electrolyte) in Dextrose 5% Injection ...........
Isolyte R (multi-electrolyte) in Dextrose 5% Injection ...........
Isolyte E (multi-electrolyte) in Dextrose 5% Injection ...........
Sodium Lactate Injection USP, 1/6 molar .............................
Travasol (amino acids) Injection With Electrolytes in Dextrose.
Travasol (amino acids) Injection With Electrolytes ...............
Nicotrol (nicotine transdermal system), 15 mg .....................
NDA 021260 ............
Sodium Lactate Injection USP, 1/6 molar .............................
Travasol (amino acids) Injection With Electrolytes in Dextrose.
Travasol (amino acids) Injection With Electrolytes ...............
Acular PF (ketorolac tromethamine) Ophthalmic Solution,
0.5%.
Avinza (morphine sulfate) Extended-Release Capsules .......
NDA 021415 ............
Metvixia (methyl aminolevulinate HCl) Cream, 16.8% ..........
NDA 021460 ............
Metaglip (glipizide and metformin HCl) Tablets, 2.5 mg/250
mg, 2.5 mg/500 mg, and 5 mg/500 mg.
Synthetic Conjugated Estrogens, A Vaginal Cream, 0.625
mg/gram (g).
Simvastatin Orally Disintegrating Tablets, 10 mg, 20 mg, 40
mg, and 80 mg.
Digoxin Injection USP Carpuject, 250 micrograms (mcg)/mL
Methotrexate Tablets USP, 2.5 mg .......................................
NDA 020177 ............
NDA 020811 ............
NDA 021788 ............
NDA 021961 ............
ANDA 040093 .........
ANDA 040233 .........
ANDA 040285 .........
Hydrocodone Bitartrate and Homatropine Methylbromide
Syrup, 5 mg/5 mL and 1.5 mg/5 mL.
ANDA 040287 .........
ANDA 040435 .........
Prednisolone Syrup, 15 mg/5 mL ..........................................
Extended Phenytoin Sodium Capsules USP, 100 mg ..........
ANDA 040443 .........
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg.
Tao (troleandomycin) Capsule ..............................................
Spectrobid (bacampicillin HCl) Tablets .................................
Spectrobid (bacampicillin HCl) Oral Suspension ..................
Azithromycin for Injection, 500 mg/vial and 2.5 g/vial ..........
mstockstill on DSK4VPTVN1PROD with NOTICES
NDA
NDA
NDA
NDA
050336
050520
050556
050809
............
............
............
............
ANDA 061370 .........
ANDA 061461 .........
ANDA 062338 .........
ANDA
ANDA
ANDA
ANDA
062391
062418
062645
062646
VerDate Sep<11>2014
.........
.........
.........
.........
Ampicillin Trihydrate for Oral Suspension, 125 mg/5 mL,
250 mg/5 mL.
Erythromycin Stearate Tablets USP, 250 mg and 500 mg ..
Eryc (erythromycin delayed-release capsules USP), 250
mg.
Doxycycline Hyclate Tablets USP, 100 mg ..........................
Doxycycline Hyclate Capsules USP, 50 mg and 100 mg .....
Griseofulvin Tablets USP, 165 mg ........................................
Ultramicrosize Griseofulvin Tablets USP, 330 mg ................
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Roche Palo Alto LLC, c/o Genetech, Inc., 1 DNA Way,
South San Francisco, CA 94080–4990.
Hospira, Inc.
Do.
Do.
B. Braun Medical Inc.
Merck Sharp & Dohme Corp.
B. Braun Medical Inc.
Do.
Do.
Do.
Baxter Healthcare Corp.
Do.
McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort
Washington, PA 19034.
B. Braun Medical Inc.
Baxter Healthcare Corp.
Do.
Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA
92623–9534.
King Pharmaceuticals LLC, 235 East 42nd St., New York,
NY 10017.
Galderma Laboratories, L.P., 14501 North Freeway, Fort
Worth, TX 76177.
Bristol-Myers Squibb, P.O. Box 4000 (Mailstop D12–02),
Princeton, NJ 08543–4000.
Teva Women’s Health, Inc., 41 Moores Rd., P.O. Box
4011, Frazer, PA 19355.
Synthon Pharmaceuticals, Inc., 9000 Development Dr.,
P.O. Box 110487, Research Triangle Park, NC 27709.
Hospira, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ
07677.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake,
NJ 07677.
Do.
ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette,
MN 56623.
Watson Laboratories, Inc.—Florida, 2945 West Corporate
Lakes Blvd., Suite B, Weston, FL 33331.
Pfizer, Inc., 235 East 42nd St., New York, NY 10017.
Do.
Do.
Teva Parenteral Medicines, Inc., Subsidiary of Teva Pharmaceuticals USA, 19 Hughes, Irvine, CA 92618–1902.
Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA
19044.
ANI Pharmaceuticals, Inc.
Warner Chilcott (US) Inc., 100 Enterprise Dr., Rockaway,
NJ 07866.
Mutual Pharmaceutical Co., Inc.
Do.
Barr Laboratories, Inc.
Do.
E:\FR\FM\13OCN1.SGM
13OCN1
61428
Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 062777 .........
Cephalexin for Oral Suspension USP, 250 mg/5 mL ...........
ANDA
ANDA
ANDA
ANDA
ANDA
062778
062826
062827
062895
062930
.........
.........
.........
.........
.........
Cephalexin for Oral Suspension USP, 125 mg/5 mL ...........
Cephalexin Tablets USP, 250 mg .........................................
Cephalexin Tablets USP, 500 mg .........................................
Cyclacillin Tablets, 250 mg and 500 mg ...............................
Clindamycin Phosphate Topical Solution, 1% ......................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
064061
064070
064085
064086
064087
065297
.........
.........
.........
.........
.........
.........
Cefaclor Capsules USP, 250 mg and 500 mg ......................
Cefaclor Oral Suspension USP, 375 mg/5 mL .....................
Cefaclor Oral Suspension USP, 250 mg/5 mL .....................
Cefaclor Oral Suspension UPS, 187 mg/5 mL .....................
Cefaclor Oral Suspension USP, 125 mg/5 mL .....................
Azithromycin for Oral Suspension, 100 mg/5 mL and 200
mg/5 mL.
Indomethacin Capsules USP, 25 mg ....................................
Indomethacin Capsules USP, 50 mg ....................................
Ibuprofen Tablets, 400 mg ....................................................
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 425 Privet Rd., Horsham, PA 19044.
Do.
Do.
Do.
Teva Pharmaceuticals, USA.
Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL
35811.
Ivax Pharmaceuticals, Inc.
Do.
Do.
Do.
Do.
Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 070067 .........
ANDA 070068 .........
ANDA 070081 .........
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
070466
070467
070472
070473
070474
070482
070483
070578
070795
.........
.........
.........
.........
.........
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
ANDA
070819
071259
071315
071769
072126
.........
.........
.........
.........
.........
Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/
80 mg.
Allopurinol Tablets USP, 100 mg ..........................................
Allopurinol Tablets USP, 300 mg ..........................................
Lorazepam Tablets USP, 0.5 mg ..........................................
Lorazepam Tablets USP, 1 mg .............................................
Lorazepam Tablets USP, 2 mg .............................................
Verapamil HCl Tablets, 80 mg ..............................................
Verapamil HCl Tablets, 120 mg ............................................
Furosemide Injection USP, 10 mg/mL ..................................
Amiloride HCl and Hydrochlorothiazide Tablets USP, 5 mg/
50 mg.
Metoclopramide Oral Solution USP, 5 mg/5 mL ...................
Trimethoprim Tablets, 200 mg ..............................................
Metoclopramide Oral Solution USP, 5 mg/5 mL ...................
Ibuprofen Tablets USP, 800 mg ............................................
Methyldopa Tablets, 125 mg .................................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
mstockstill on DSK4VPTVN1PROD with NOTICES
ANDA 070215 .........
072127
072128
072557
072779
072780
073115
073478
073497
073504
074101
074103
074148
074344
074345
074347
074348
074368
074390
074401
074402
074411
074500
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
Methyldopa Tablets, 250 mg .................................................
Methyldopa Tablets, 500 mg .................................................
Fenoprofen Calcium Tablets USP, 600 mg ..........................
Albuterol Tablets USP, 2 mg .................................................
Albuterol Tablets USP, 4 mg .................................................
Amantadine HCl Oral Solution USP, 50 mg/5 mL ................
Loperamide HCl Oral Solution, 1 mg/5 mL ...........................
Lactulose Solution USP, 10 g/15 mL (Evalose) ....................
Lactulose Solution USP, 10 g/15 mL (Heptalac) ..................
Atenolol Tablets, 25 mg, 50 mg, and 100 mg ......................
Piroxicam Capsules USP, 10 mg and 20 mg .......................
Piroxicam Capsules USP, 10 mg and 20 mg .......................
Cimetidine Injection USP, 300 mg/2 mL ...............................
Cimetidine Injection USP, 300 mg/2 mL ...............................
Cholestyramine for Oral Suspension USP, 4 g ....................
Cholestyramine for Oral Suspension USP, 4 g ....................
Nadolol Tablets USP, 80 mg, 120 mg, and 160 mg .............
Diclofenac Sodium Delayed-Release Tablets USP, 75 mg ..
Cimetidine Tablets USP, 200 mg, 300 mg, and 400 mg ......
Cimetidine Tablets USP, 800 mg ..........................................
Flurbiprofen Tablets USP, 50 mg and 100 mg .....................
Minoxidil Topical Solution, 2% ..............................................
ANDA 074530 .........
ANDA 074590 .........
ANDA 074619 .........
Terazosin HCl Tablets, 1 mg, 2 mg, 5 mg, and 10 mg ........
Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100
mg.
Glipizide Tablets USP, 5 mg and 10 mg ..............................
ANDA
ANDA
ANDA
ANDA
Cimetidine HCl Oral Solution, 300 mg/5 mL .........................
Tretinoin Topical Solution USP, 0.05% .................................
Etodolac Capsules USP, 200 mg and 300 mg .....................
Clonazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg ............
074859
074873
074899
074920
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.........
.........
.........
.........
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Mutual Pharmaceutical Co., Inc.
Do.
McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort
Washington, PA 19034.
Pliva Inc., Subsidiary of Teva Pharmaceuticals USA, 425
Privet Rd., Horsham, PA 19044.
Mutual Pharmaceutical Co., Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Teva Pharmaceuticals USA.
Do.
Do.
Do.
Ivax Pharmaceuticals, Inc.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ
07677.
Do.
Do.
Ivax Pharmaceuticals, Inc.
Teva Pharmaceuticals USA.
Do.
Do.
Do.
Do.
Do.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
Teva Pharmaceuticals USA.
Ivax Pharmaceuticals, Inc.
Hospira, Inc.
Do.
Teva Pharmaceuticals USA.
Do.
Do.
Do.
Ivax Pharmaceuticals, Inc.
Do.
Do.
Copley Pharmaceutical, Inc., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
Ivax Pharmaceuticals, Inc.
Do.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ
07677.
ANI Pharmaceuticals, Inc.
Teva Pharmaceuticals USA.
ANI Pharmaceuticals, Inc.
Teva Pharmaceuticals USA.
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Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
61429
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 075020 .........
Hydroxyurea Capsule USP, 250 mg and 500 mg ................
ANDA 075055 .........
Captopril and Hydrochlorothiazide Tablets USP, 25/15 mg,
25/25 mg, 50/15 mg, and 50/25 mg.
Cimetidine HCl Solution, 300 mg/5 mL .................................
Isosorbide Mononitrate Extended-Release Tablets, 30 mg,
60 mg, and 120 mg.
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and
20 mg.
Hydroxyurea Tablets USP, 1,000 mg ...................................
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ
07677.
Ivax Pharmaceuticals, Inc.
ANDA 075110 .........
ANDA 075448 .........
ANDA 075482 .........
ANDA 075734 .........
ANDA 075763 .........
ANDA 076136 .........
ANDA 076169 .........
ANDA 076752 .........
Nefazodone HCl Tablets USP, 50 mg, 100 mg, 150 mg,
200 mg, and 250 mg.
Ciprofloxacin Tablets USP, 250 mg, 500 mg, and 750 mg ..
Fexofenadine HCl Capsules, 60 mg .....................................
ANDA 077176 .........
ANDA 077779 .........
ANDA 080391 .........
Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75
mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg,
175 mcg, 200 mcg, and 300 mcg.
Prednisolone Sodium Phosphate Oral Solution USP, Prednisolone Base 15 mg/5 mL.
Metoprolol Succinate Extended-Release Tablets, 50 mg .....
Metoprolol Sucinate Extended-Release Tablets, 25 mg .......
Edetate Calcium Disodium Injection .....................................
ANDA 080505 .........
Carmol HC Cream .................................................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
080701
081054
083729
083734
083740
084106
084107
084506
084595
084606
084634
084978
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
085627
085742
085743
085744
085745
085836
086595
087265
087267
.........
.........
.........
.........
.........
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
087292
087293
087857
087860
087913
088409
088626
.........
.........
.........
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
088728
088804
088883
088884
.........
.........
.........
.........
Prednisone Tablets USP, 5 mg .............................................
Hydroxyzine HCl Tablets, 100 mg ........................................
Imipramine HCl Tablets USP, 10 mg, 25 mg, and 50 mg ....
Probenecid and Colchicine Tablets USP, 500 mg/0.5 mg ...
Probenecid Tablets USP, 500 mg .........................................
Hydralazine HCl Tablets USP, 25 mg ...................................
Hydralazine HCl Tablets USP, 50 mg ...................................
Diphenhydramine HCl Capsules USP, 25 mg ......................
Procainainde HCl Capsules USP, 375 mg ...........................
Procainamide HCl Capsules USP, 500 mg ..........................
Prednisone Tablets USP, 20 mg ...........................................
Micrainin (aspirin and meprobamate) Tablets, 325 mg/200
mg.
Amitriptyline HCl Tablets USP, 25 mg ..................................
Amitriptyline HCl Tablets USP, 100 mg ................................
Amitriptyline HCl Tablets USP, 75 mg ..................................
Amitriptyline HCl Tablets USP, 10 mg ..................................
Amitriptyline HCl Tablets USP, 50 mg ..................................
Amitriptyline HCl Tablets USP, 100 mg ................................
Prednisone Tablets USP, 10 mg ...........................................
Spironolactone Tablets USP, 25 mg .....................................
Spironolactone and Hydrochlorothiazide Tablets USP, 25
mg/25 mg.
Chlorthalidone Tablets USP, 25 mg ......................................
Chlorthalidone Tablets USP, 50 mg ......................................
Hydroxyzine HCl Tablets USP, 25 mg ..................................
Hydroxyzine HCl Tablets USP, 50 mg ..................................
Methyclothiazide Tablets USP, 2.5 mg .................................
Hydroxyzine HCl Tablets USP, 10 mg ..................................
Bromodiphenhydramine HCl and Codeine Phosphate
Syrup, 12.5 mg/5 mL and 10 mg/5 mL.
Hydralazine HCl Tablets USP, 10 mg ...................................
Trimethobenzamide HCl Injection USP, 100 mg/mL ............
Amitriptyline HCl Tablets USP, 10 mg ..................................
Amitriptyline HCl Tablets USP, 25 mg ..................................
ANDA
ANDA
ANDA
ANDA
088885
088886
088887
088888
.........
.........
.........
.........
Amitriptyline
Amitriptyline
Amitriptyline
Amitriptyline
mstockstill on DSK4VPTVN1PROD with NOTICES
ANDA 076988 .........
ANDA 088891 .........
VerDate Sep<11>2014
HCl
HCl
HCl
HCl
Tablets
Tablets
Tablets
Tablets
USP,
USP,
USP,
USP,
50 mg ..................................
75 mg ..................................
100 mg ................................
150 mg ................................
Ergoloid Mesylates Tablets USP, 1 mg ................................
21:23 Oct 09, 2015
Jkt 238001
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ANI Pharmaceuticals, Inc.
Ivax Pharmaceuticals, Inc.
Do.
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ
07677.
Ivax Pharmaceuticals, Inc.
Teva Pharmaceuticals USA.
Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff
Lake, NJ 07677.
Merck KGaA, c/o Icon Clinical Research, 212 Church Rd.,
North Wales, PA 19454.
Nesher Pharmaceuticals (USA) LLC, 13910 Saint Charles
Rock Rd., Bridgeton, MO 63044.
Do.
Do.
Watson Laboratories, Inc., Morris Corporate Center III, 400
Interpace Parkway, Parsippany, NJ 07054.
Fougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box
2006, Melville, NY 11747.
Mutual Pharmaceutical Co., Inc.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
Teva Pharmaceuticals USA.
Ivax Pharmaceuticals, Inc.
Do.
Mutual Pharmaceutical Co., Inc.
Do.
Do.
Ivax Pharmaceuticals, Inc.
Do.
Mutual Pharmaceutical Co., Inc.
Meda Pharmaceuticals Inc.
Mutual Pharmaceutical Co., Inc.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA.
Mutual Pharmaceutical Co., Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Ivax Pharmaceuticals, Inc.
Mutual Pharmaceutical Co., Inc.
Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals,
Inc., 6451 Main St., Morton Grove, IL 60053.
Mutual Pharmaceutical Co., Inc.
Hospira, Inc.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
Pliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceuticals
USA, 425 Privet Rd., Horsham, PA 19044.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
Do.
Do.
Pliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceuticals
USA.
Mutual Pharmaceutical Co., Inc.
E:\FR\FM\13OCN1.SGM
13OCN1
61430
Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 089238 .........
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/30 mg.
Acetaminophen and Codeine Phosphate Tablets USP, 300
mg/60 mg.
Amitriptyline HCl Tablets USP, 150 mg ................................
Oxaliplatin for Injection USP, 50 mg/vial and 100 mg/vial ....
Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
ANDA 089244 .........
ANDA 089423 .........
ANDA 090849 .........
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) and under authority
delegated to the Director of Food and
Drugs, Center for Drug Evaluation and
Research, by the Commissioner,
approval of the applications listed in
table 1 in this document, and all
amendments and supplements thereto,
is hereby withdrawn, effective
November 12, 2015. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the 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: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25922 Filed 10–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3456]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recommended
Recordkeeping for Cosmetic Good
Manufacturing Practices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on our proposed collection of
certain information. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies must publish a
notice in the Federal Register
concerning each proposed collection of
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:23 Oct 09, 2015
Jkt 238001
Do.
Mutual Pharmaceutical Co., Inc.
Sandoz Inc., 506 Carnegie Center, Suite 400, Princeton,
NJ 08540.
information, including collections of
information in current guidance
documents, and allow 60 days for
public comment. This notice invites
comments on the recommended
recordkeeping associated with our draft
guidance entitled, ‘‘Draft Guidance for
Industry: Cosmetic Good Manufacturing
Practices.’’ Our draft guidance remains
unchanged by this notice. We are
publishing this notice in compliance
with the PRA. This notice does not
represent any new regulatory initiative.
DATES: Submit either electronic or
written comments on the collection of
information by December 14, 2015.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
PO 00000
Frm 00097
Fmt 4703
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Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked, and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–3456 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recommended Recordkeeping for
Cosmetic Good Manufacturing
Practices.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
E:\FR\FM\13OCN1.SGM
13OCN1
]]>Agencies
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61426-61430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25922]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3432]
Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug
Applications and 128 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 67 new drug applications (NDAs) and 128 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: Effective Date: November 12, 2015.
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.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 001104................ Doca Organon USA Inc.,
(desoxycorticosteron Subsidiary of Merck
e acetate) Sharp & Dohme Corp.,
Injection, 5 2000 Galloping Hill
milligrams (mg)/ Rd., Kenilworth, NJ
milliliter (mL). 07033.
NDA 004589................ Alcohol in Dextrose B. Braun Medical
Injection USP, 10 mL/ Inc., 901 Marcon
100 mL and 5 grams Blvd., Allentown, PA
(g)/100 mL. 18109.
NDA 006170................ Hyprotigen (modified Do.
protein hydrolysate)
Injection, 5%.
NDA 012154................ Ureaphil (urea) for Hospira, Inc., 275
Injection, 40 g/vial. North Field Dr.,
Lake Forest, IL
60045.
NDA 012449................ Oratrol Alcon Laboratories
(dichlorphenamide) Inc., 6201 South
Tablets, 50 mg. Freeway, P.O. Box
1959, Fort Worth, TX
76134.
NDA 012699................ Lomotil (atropine G.D. Searle, LLC, 235
sulfate and East 42nd St., New
diphenoxylate York, NY 10017.
hydrochloride (HCl))
Solution 0.025 mg/5
mL and 2.5 mg/5 mL.
NDA 012892................ Uracil Mustard Shire Development
Capsule. Inc., 725
Chesterbrook Blvd.,
Wayne, PA 19087-
5637.
NDA 014738................ Mannitol Injection B. Braun Medical Inc.
USP, 20%.
NDA 016080................ Mannitol Injection Do.
USP.
NDA 016096................ Mintezol Merck Sharp & Dohme
(thiabendazole) Corp., 1 Merck
Tablets. Drive, P.O. Box 100,
Whitehouse Station,
NJ 08889.
NDA 016097................ Mintezol Do.
(thiabendazole) Oral
Suspension.
NDA 016695................ Dextrose Injection, Baxter Healthcare
5% (in Ringer's). Corp. 32650 N.
Wilson Rd., Round
Lake, IL 60073.
NDA 017390................ Plasma-Lyte M and Do.
Dextrose 5%
Injection.
NDA 017438................ Plasma-Lyte R Do.
Injection.
NDA 017451................ Plasma Lyte 148 and Do.
Dextrose 5%
Injection.
NDA 017493................ Travasol (amino Do.
acids) Injection,
10%.
NDA 017510................ Dextrose 5% Injection B. Braun Medical Inc.
(in lactated
Ringer's).
NDA 017636................ Sorbitol-Mannitol Hospira, Inc.
Irrigation, 2.7 g/
100 mL-540 mg/100 mL.
NDA 017698................ Serile Urea Injection Do.
NDA 017911................ Clinoril (sulindac) Merck Sharp & Dohme
Tablets, 150 mg and Corp.
200 mg.
NDA 017957................ Novamine (amino Hospira, Inc.
acids) Injection.
NDA 017995................ Dextrose Injection B. Braun Medical Inc.
USP, 60%.
NDA 018191................ Drixoral Non-Drowsy MSD Consumer Care,
(pseudoephedrine Inc., 556 Morris
sulfate) Extended- Ave., Summit, NJ
Release Tablets, 120 07901.
mg.
NDA 018242................ Sulfamethoxazole and Teva Pharmaceuticals
Trimethorim Tablets USA, 425 Privet Rd.,
USP. Horsham, PA 19044.
NDA 018258................ Dextrose Injection 5% B. Braun Medical Inc.
(in acetated
Ringer's).
NDA 018268................ Dextrose, Sodium Do.
Chloride, and
Potassium Chloride
Injection USP, 5%.
NDA 018307................ Thyro-Block Meda Pharmaceuticals
(potassium iodide Inc., 265 Davidson
tablets USP). Ave., Suite 400,
Somerset, NJ 08873.
NDA 018308................ Thyro-Block Do.
(potassium iodide
solution), 21 mg.
NDA 018312................ Calderol Organon USA Inc.,
(calcifediol) Subsidiary of Merck
Capsules. & Co., Inc.
NDA 018376................ Dextrose and Sodium B. Braun Medical Inc.
Chloride Injection,
2.5%/0.9%.
NDA 018531................ Nitroglycerin Hospira, Inc.
Injection USP, 5 mg/
mL.
NDA 018533................ Nizoral Janssen
(ketoconazole) Pharmaceuticals,
Tablets, 200 mg. Inc., c/o Janssen
Research &
Development, LLC,
920 Route 202 South,
P.O. Box 300,
Raritan, NJ 08869-
0602.
NDA 018684................ Branchamin (amino Baxter Healthcare
acids) Injection, 4%. Corp.
NDA 018722................ Sodium Chloride 0.9%, B. Braun Medical Inc.
and Potassium
Chloride Injection.
NDA 018725................ Acetated Ringer's Do.
Injection.
[[Page 61427]]
NDA 018744................ Dextrose and Do.
Potassium Chloride
Injection.
NDA 018818................ Metronidazole Tablets Mutual Pharmaceutical
USP, 250 mg and 500 Co., Inc., 1100
mg. Orthodox St.,
Philadelphia, PA
19124.
NDA 018840................ Dextrose 5%, and Baxter Healthcare
Electrolyte No. 75 Corp.
Injection.
NDA 019037................ Imodium (loperamide Janssen
HCl) Oral Solution, Pharmaceuticals,
1 mg/5 mL. Inc., c/o Janssen
Research &
Development, LLC,
1125 Trenton-
Harbourton Rd., P.O.
Box 200, Titusville,
NJ 08560.
NDA 019047................ Plasma-Lyte 56 Baxter Healthcare
(electrolyte Corp.
solution) Injection.
NDA 019439................ K-Dur (potassium Merck Sharp & Dohme
chloride) Extended- Corp.
Release Tablets, 10
milliequivalents
(mEq) and 20 mEq.
NDA 019645................ Toradol (ketorolac Roche Palo Alto LLC,
tromethamine) c/o Genetech, Inc.,
Tablets, 10 mg. 1 DNA Way, South San
Francisco, CA 94080-
4990.
NDA 019681................ Aminosyn II in Hospira, Inc.
Dextrose Injection.
NDA 019682................ Aminosyn II with Do.
Electrolytes and
Adjusted Phosphate
in Dextrose
Injection.
NDA 019683................ Aminosyn II with Do.
Electrolytes in
Dextrose with
Calcium Injection.
NDA 019718................ Isolyte E (multi- B. Braun Medical Inc.
electrolyte)
Injection.
NDA 019778................ Prinzide (lisinopril Merck Sharp & Dohme
and Corp.
hydrochlorothiazide)
Tablets, 10 mg/12.5
mg, 20 mg/12.5 mg,
and 20 mg/25 mg.
NDA 019843................ Isolyte S (multi- B. Braun Medical Inc.
electrolyte) in
Dextrose 5%
Injection.
NDA 019864................ Isolyte R (multi- Do.
electrolyte) in
Dextrose 5%
Injection.
NDA 019867................ Isolyte E (multi- Do.
electrolyte) in
Dextrose 5%
Injection.
NDA 020004................ Sodium Lactate Do.
Injection USP, 1/6
molar.
NDA 020173................ Travasol (amino Baxter Healthcare
acids) Injection Corp.
With Electrolytes in
Dextrose.
NDA 020177................ Travasol (amino Do.
acids) Injection
With Electrolytes.
NDA 020536................ Nicotrol (nicotine McNeil Consumer
transdermal system), Healthcare, 7050
15 mg. Camp Hill Rd., Fort
Washington, PA
19034.
NDA 020004................ Sodium Lactate B. Braun Medical Inc.
Injection USP, 1/6
molar.
NDA 020173................ Travasol (amino Baxter Healthcare
acids) Injection Corp.
With Electrolytes in
Dextrose.
NDA 020177................ Travasol (amino Do.
acids) Injection
With Electrolytes.
NDA 020811................ Acular PF (ketorolac Allergan, Inc., 2525
tromethamine) Dupont Dr., P.O. Box
Ophthalmic Solution, 19534, Irvine, CA
0.5%. 92623-9534.
NDA 021260................ Avinza (morphine King Pharmaceuticals
sulfate) Extended- LLC, 235 East 42nd
Release Capsules. St., New York, NY
10017.
NDA 021415................ Metvixia (methyl Galderma
aminolevulinate HCl) Laboratories, L.P.,
Cream, 16.8%. 14501 North Freeway,
Fort Worth, TX
76177.
NDA 021460................ Metaglip (glipizide Bristol-Myers Squibb,
and metformin HCl) P.O. Box 4000
Tablets, 2.5 mg/250 (Mailstop D12-02),
mg, 2.5 mg/500 mg, Princeton, NJ 08543-
and 5 mg/500 mg. 4000.
NDA 021788................ Synthetic Conjugated Teva Women's Health,
Estrogens, A Vaginal Inc., 41 Moores Rd.,
Cream, 0.625 mg/gram P.O. Box 4011,
(g). Frazer, PA 19355.
NDA 021961................ Simvastatin Orally Synthon
Disintegrating Pharmaceuticals,
Tablets, 10 mg, 20 Inc., 9000
mg, 40 mg, and 80 mg. Development Dr.,
P.O. Box 110487,
Research Triangle
Park, NC 27709.
ANDA 040093............... Digoxin Injection USP Hospira, Inc.
Carpuject, 250
micrograms (mcg)/mL.
ANDA 040233............... Methotrexate Tablets Barr Laboratories,
USP, 2.5 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 040285............... Hydrocodone Ivax Pharmaceuticals,
Bitartrate and Inc., Subsidiary of
Homatropine Teva Pharmaceuticals
Methylbromide Syrup, USA, 400 Chestnut
5 mg/5 mL and 1.5 mg/ Ridge Rd., Woodcliff
5 mL. Lake, NJ 07677.
ANDA 040287............... Prednisolone Syrup, Do.
15 mg/5 mL.
ANDA 040435............... Extended Phenytoin ANI Pharmaceuticals,
Sodium Capsules USP, Inc., 210 Main St.
100 mg. West, Baudette, MN
56623.
ANDA 040443............... Acetaminophen and Watson Laboratories,
Codeine Phosphate Inc.--Florida, 2945
Tablets USP, 300 mg/ West Corporate Lakes
15 mg, 300 mg/30 mg, Blvd., Suite B,
and 300 mg/60 mg. Weston, FL 33331.
NDA 050336................ Tao (troleandomycin) Pfizer, Inc., 235
Capsule. East 42nd St., New
York, NY 10017.
NDA 050520................ Spectrobid Do.
(bacampicillin HCl)
Tablets.
NDA 050556................ Spectrobid Do.
(bacampicillin HCl)
Oral Suspension.
NDA 050809................ Azithromycin for Teva Parenteral
Injection, 500 mg/ Medicines, Inc.,
vial and 2.5 g/vial. Subsidiary of Teva
Pharmaceuticals USA,
19 Hughes, Irvine,
CA 92618-1902.
ANDA 061370............... Ampicillin Trihydrate Teva Pharmaceuticals
for Oral Suspension, USA, 425 Privet Rd.,
125 mg/5 mL, 250 mg/ Horsham, PA 19044.
5 mL.
ANDA 061461............... Erythromycin Stearate ANI Pharmaceuticals,
Tablets USP, 250 mg Inc.
and 500 mg.
ANDA 062338............... Eryc (erythromycin Warner Chilcott (US)
delayed-release Inc., 100 Enterprise
capsules USP), 250 Dr., Rockaway, NJ
mg. 07866.
ANDA 062391............... Doxycycline Hyclate Mutual Pharmaceutical
Tablets USP, 100 mg. Co., Inc.
ANDA 062418............... Doxycycline Hyclate Do.
Capsules USP, 50 mg
and 100 mg.
ANDA 062645............... Griseofulvin Tablets Barr Laboratories,
USP, 165 mg. Inc.
ANDA 062646............... Ultramicrosize Do.
Griseofulvin Tablets
USP, 330 mg.
[[Page 61428]]
ANDA 062777............... Cephalexin for Oral Barr Laboratories,
Suspension USP, 250 Inc., Subsidiary of
mg/5 mL. Teva Pharmaceuticals
USA, 425 Privet Rd.,
Horsham, PA 19044.
ANDA 062778............... Cephalexin for Oral Do.
Suspension USP, 125
mg/5 mL.
ANDA 062826............... Cephalexin Tablets Do.
USP, 250 mg.
ANDA 062827............... Cephalexin Tablets Do.
USP, 500 mg.
ANDA 062895............... Cyclacillin Tablets, Teva Pharmaceuticals,
250 mg and 500 mg. USA.
ANDA 062930............... Clindamycin Phosphate Vintage
Topical Solution, 1%. Pharmaceuticals, 150
Vintage Dr.,
Huntsville, AL
35811.
ANDA 064061............... Cefaclor Capsules Ivax Pharmaceuticals,
USP, 250 mg and 500 Inc.
mg.
ANDA 064070............... Cefaclor Oral Do.
Suspension USP, 375
mg/5 mL.
ANDA 064085............... Cefaclor Oral Do.
Suspension USP, 250
mg/5 mL.
ANDA 064086............... Cefaclor Oral Do.
Suspension UPS, 187
mg/5 mL.
ANDA 064087............... Cefaclor Oral Do.
Suspension USP, 125
mg/5 mL.
ANDA 065297............... Azithromycin for Oral Sandoz Inc., 4700
Suspension, 100 mg/5 Sandoz Dr., Wilson,
mL and 200 mg/5 mL. NC 27893.
ANDA 070067............... Indomethacin Capsules Mutual Pharmaceutical
USP, 25 mg. Co., Inc.
ANDA 070068............... Indomethacin Capsules Do.
USP, 50 mg.
ANDA 070081............... Ibuprofen Tablets, McNeil Consumer
400 mg. Healthcare, 7050
Camp Hill Rd., Fort
Washington, PA
19034.
ANDA 070215............... Sulfamethoxazole and Pliva Inc.,
Trimethoprim Tablets Subsidiary of Teva
USP, 400 mg/80 mg. Pharmaceuticals USA,
425 Privet Rd.,
Horsham, PA 19044.
ANDA 070466............... Allopurinol Tablets Mutual Pharmaceutical
USP, 100 mg. Co., Inc.
ANDA 070467............... Allopurinol Tablets Do.
USP, 300 mg.
ANDA 070472............... Lorazepam Tablets Do.
USP, 0.5 mg.
ANDA 070473............... Lorazepam Tablets Do.
USP, 1 mg.
ANDA 070474............... Lorazepam Tablets Do.
USP, 2 mg.
ANDA 070482............... Verapamil HCl Do.
Tablets, 80 mg.
ANDA 070483............... Verapamil HCl Do.
Tablets, 120 mg.
ANDA 070578............... Furosemide Injection Hospira, Inc.
USP, 10 mg/mL.
ANDA 070795............... Amiloride HCl and Teva Pharmaceuticals
Hydrochlorothiazide USA.
Tablets USP, 5 mg/50
mg.
ANDA 070819............... Metoclopramide Oral Do.
Solution USP, 5 mg/5
mL.
ANDA 071259............... Trimethoprim Tablets, Do.
200 mg.
ANDA 071315............... Metoclopramide Oral Do.
Solution USP, 5 mg/5
mL.
ANDA 071769............... Ibuprofen Tablets Ivax Pharmaceuticals,
USP, 800 mg. Inc.
ANDA 072126............... Methyldopa Tablets, Barr Laboratories,
125 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 072127............... Methyldopa Tablets, Do.
250 mg.
ANDA 072128............... Methyldopa Tablets, Do.
500 mg.
ANDA 072557............... Fenoprofen Calcium Ivax Pharmaceuticals,
Tablets USP, 600 mg. Inc.
ANDA 072779............... Albuterol Tablets Teva Pharmaceuticals
USP, 2 mg. USA.
ANDA 072780............... Albuterol Tablets Do.
USP, 4 mg.
ANDA 073115............... Amantadine HCl Oral Do.
Solution USP, 50 mg/
5 mL.
ANDA 073478............... Loperamide HCl Oral Do.
Solution, 1 mg/5 mL.
ANDA 073497............... Lactulose Solution Do.
USP, 10 g/15 mL
(Evalose).
ANDA 073504............... Lactulose Solution Do.
USP, 10 g/15 mL
(Heptalac).
ANDA 074101............... Atenolol Tablets, 25 Pliva, Inc.,
mg, 50 mg, and 100 Subsidiary of Teva
mg. Pharmaceuticals USA.
ANDA 074103............... Piroxicam Capsules Teva Pharmaceuticals
USP, 10 mg and 20 mg. USA.
ANDA 074148............... Piroxicam Capsules Ivax Pharmaceuticals,
USP, 10 mg and 20 mg. Inc.
ANDA 074344............... Cimetidine Injection Hospira, Inc.
USP, 300 mg/2 mL.
ANDA 074345............... Cimetidine Injection Do.
USP, 300 mg/2 mL.
ANDA 074347............... Cholestyramine for Teva Pharmaceuticals
Oral Suspension USP, USA.
4 g.
ANDA 074348............... Cholestyramine for Do.
Oral Suspension USP,
4 g.
ANDA 074368............... Nadolol Tablets USP, Do.
80 mg, 120 mg, and
160 mg.
ANDA 074390............... Diclofenac Sodium Do.
Delayed-Release
Tablets USP, 75 mg.
ANDA 074401............... Cimetidine Tablets Ivax Pharmaceuticals,
USP, 200 mg, 300 mg, Inc.
and 400 mg.
ANDA 074402............... Cimetidine Tablets Do.
USP, 800 mg.
ANDA 074411............... Flurbiprofen Tablets Do.
USP, 50 mg and 100
mg.
ANDA 074500............... Minoxidil Topical Copley
Solution, 2%. Pharmaceutical,
Inc., Subsidiary of
Teva Pharmaceuticals
USA, 425 Privet Rd.,
Horsham, PA 19044.
ANDA 074530............... Terazosin HCl Ivax Pharmaceuticals,
Tablets, 1 mg, 2 mg, Inc.
5 mg, and 10 mg.
ANDA 074590............... Captopril Tablets Do.
USP, 12.5 mg, 25 mg,
50 mg, and 100 mg.
ANDA 074619............... Glipizide Tablets Barr Laboratories,
USP, 5 mg and 10 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 074859............... Cimetidine HCl Oral ANI Pharmaceuticals,
Solution, 300 mg/5 Inc.
mL.
ANDA 074873............... Tretinoin Topical Teva Pharmaceuticals
Solution USP, 0.05%. USA.
ANDA 074899............... Etodolac Capsules ANI Pharmaceuticals,
USP, 200 mg and 300 Inc.
mg.
ANDA 074920............... Clonazepam Tablets Teva Pharmaceuticals
USP, 0.5 mg, 1 mg, USA.
and 2 mg.
[[Page 61429]]
ANDA 075020............... Hydroxyurea Capsule Barr Laboratories,
USP, 250 mg and 500 Inc., Subsidiary of
mg. Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 075055............... Captopril and Ivax Pharmaceuticals,
Hydrochlorothiazide Inc.
Tablets USP, 25/15
mg, 25/25 mg, 50/15
mg, and 50/25 mg.
ANDA 075110............... Cimetidine HCl ANI Pharmaceuticals,
Solution, 300 mg/5 Inc.
mL.
ANDA 075448............... Isosorbide Ivax Pharmaceuticals,
Mononitrate Extended- Inc.
Release Tablets, 30
mg, 60 mg, and 120
mg.
ANDA 075482............... Enalapril Maleate Do.
Tablets USP, 2.5 mg,
5 mg, 10 mg, and 20
mg.
ANDA 075734............... Hydroxyurea Tablets Barr Laboratories,
USP, 1,000 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 075763............... Nefazodone HCl Ivax Pharmaceuticals,
Tablets USP, 50 mg, Inc.
100 mg, 150 mg, 200
mg, and 250 mg.
ANDA 076136............... Ciprofloxacin Tablets Teva Pharmaceuticals
USP, 250 mg, 500 mg, USA.
and 750 mg.
ANDA 076169............... Fexofenadine HCl Barr Laboratories,
Capsules, 60 mg. Inc., 400 Chestnut
Ridge Rd., Woodcliff
Lake, NJ 07677.
ANDA 076752............... Levothyroxine Sodium Merck KGaA, c/o Icon
Tablets USP, 25 mcg, Clinical Research,
50 mcg, 75 mcg, 88 212 Church Rd.,
mcg, 100 mcg, 112 North Wales, PA
mcg, 125 mcg, 150 19454.
mcg, 175 mcg, 200
mcg, and 300 mcg.
ANDA 076988............... Prednisolone Sodium Nesher
Phosphate Oral Pharmaceuticals
Solution USP, (USA) LLC, 13910
Prednisolone Base 15 Saint Charles Rock
mg/5 mL. Rd., Bridgeton, MO
63044.
ANDA 077176............... Metoprolol Succinate Do.
Extended-Release
Tablets, 50 mg.
ANDA 077779............... Metoprolol Sucinate Do.
Extended-Release
Tablets, 25 mg.
ANDA 080391............... Edetate Calcium Watson Laboratories,
Disodium Injection. Inc., Morris
Corporate Center
III, 400 Interpace
Parkway, Parsippany,
NJ 07054.
ANDA 080505............... Carmol HC Cream...... Fougera
Pharmaceuticals
Inc., 60 Baylis Rd.,
P.O. Box 2006,
Melville, NY 11747.
ANDA 080701............... Prednisone Tablets Mutual Pharmaceutical
USP, 5 mg. Co., Inc.
ANDA 081054............... Hydroxyzine HCl Pliva, Inc.,
Tablets, 100 mg. Subsidiary of Teva
Pharmaceuticals USA.
ANDA 083729............... Imipramine HCl Teva Pharmaceuticals
Tablets USP, 10 mg, USA.
25 mg, and 50 mg.
ANDA 083734............... Probenecid and Ivax Pharmaceuticals,
Colchicine Tablets Inc.
USP, 500 mg/0.5 mg.
ANDA 083740............... Probenecid Tablets Do.
USP, 500 mg.
ANDA 084106............... Hydralazine HCl Mutual Pharmaceutical
Tablets USP, 25 mg. Co., Inc.
ANDA 084107............... Hydralazine HCl Do.
Tablets USP, 50 mg.
ANDA 084506............... Diphenhydramine HCl Do.
Capsules USP, 25 mg.
ANDA 084595............... Procainainde HCl Ivax Pharmaceuticals,
Capsules USP, 375 mg. Inc.
ANDA 084606............... Procainamide HCl Do.
Capsules USP, 500 mg.
ANDA 084634............... Prednisone Tablets Mutual Pharmaceutical
USP, 20 mg. Co., Inc.
ANDA 084978............... Micrainin (aspirin Meda Pharmaceuticals
and meprobamate) Inc.
Tablets, 325 mg/200
mg.
ANDA 085627............... Amitriptyline HCl Mutual Pharmaceutical
Tablets USP, 25 mg. Co., Inc.
ANDA 085742............... Amitriptyline HCl Do.
Tablets USP, 100 mg.
ANDA 085743............... Amitriptyline HCl Do.
Tablets USP, 75 mg.
ANDA 085744............... Amitriptyline HCl Do.
Tablets USP, 10 mg.
ANDA 085745............... Amitriptyline HCl Do.
Tablets USP, 50 mg.
ANDA 085836............... Amitriptyline HCl Teva Pharmaceuticals
Tablets USP, 100 mg. USA.
ANDA 086595............... Prednisone Tablets Mutual Pharmaceutical
USP, 10 mg. Co., Inc.
ANDA 087265............... Spironolactone Do.
Tablets USP, 25 mg.
ANDA 087267............... Spironolactone and Do.
Hydrochlorothiazide
Tablets USP, 25 mg/
25 mg.
ANDA 087292............... Chlorthalidone Do.
Tablets USP, 25 mg.
ANDA 087293............... Chlorthalidone Do.
Tablets USP, 50 mg.
ANDA 087857............... Hydroxyzine HCl Do.
Tablets USP, 25 mg.
ANDA 087860............... Hydroxyzine HCl Do.
Tablets USP, 50 mg.
ANDA 087913............... Methyclothiazide Ivax Pharmaceuticals,
Tablets USP, 2.5 mg. Inc.
ANDA 088409............... Hydroxyzine HCl Mutual Pharmaceutical
Tablets USP, 10 mg. Co., Inc.
ANDA 088626............... Bromodiphenhydramine Wockhardt Bio AG, c/o
HCl and Codeine Morton Grove
Phosphate Syrup, Pharmaceuticals,
12.5 mg/5 mL and 10 Inc., 6451 Main St.,
mg/5 mL. Morton Grove, IL
60053.
ANDA 088728............... Hydralazine HCl Mutual Pharmaceutical
Tablets USP, 10 mg. Co., Inc.
ANDA 088804............... Trimethobenzamide HCl Hospira, Inc.
Injection USP, 100
mg/mL.
ANDA 088883............... Amitriptyline HCl Pliva, Inc.,
Tablets USP, 10 mg. Subsidiary of Teva
Pharmaceuticals USA.
ANDA 088884............... Amitriptyline HCl Pliva Hrvatska
Tablets USP, 25 mg. d.o.o., Subsidiary
of Teva
Pharmaceuticals USA,
425 Privet Rd.,
Horsham, PA 19044.
ANDA 088885............... Amitriptyline HCl Pliva, Inc.,
Tablets USP, 50 mg. Subsidiary of Teva
Pharmaceuticals USA.
ANDA 088886............... Amitriptyline HCl Do.
Tablets USP, 75 mg.
ANDA 088887............... Amitriptyline HCl Do.
Tablets USP, 100 mg.
ANDA 088888............... Amitriptyline HCl Pliva Hrvatska
Tablets USP, 150 mg. d.o.o., Subsidiary
of Teva
Pharmaceuticals USA.
ANDA 088891............... Ergoloid Mesylates Mutual Pharmaceutical
Tablets USP, 1 mg. Co., Inc.
[[Page 61430]]
ANDA 089238............... Acetaminophen and Mikart, Inc., 1750
Codeine Phosphate Chattahoochee Ave.,
Tablets USP, 300 mg/ Atlanta, GA 30318.
30 mg.
ANDA 089244............... Acetaminophen and Do.
Codeine Phosphate
Tablets USP, 300 mg/
60 mg.
ANDA 089423............... Amitriptyline HCl Mutual Pharmaceutical
Tablets USP, 150 mg. Co., Inc.
ANDA 090849............... Oxaliplatin for Sandoz Inc., 506
Injection USP, 50 mg/ Carnegie Center,
vial and 100 mg/vial. Suite 400,
Princeton, NJ 08540.
------------------------------------------------------------------------
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director of Food and Drugs, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective November 12, 2015. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the 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: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25922 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P
