Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications, 56976-56978 [2017-25920]
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Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
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Dated: November 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25911 Filed 11–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6591]
Barr Laboratories, Inc. et al.;
Withdrawal of Approval of 68
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 68 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withdrawn.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:
Approval is withdrawn as of
January 2, 2018.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945.
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:
TABLE 1
Application No.
Drug
Applicant
ANDA 040135 .........
Estropipate Tablets USP, 0.75 milligrams (mg), 1.5 mg,
and 3 mg.
Carisoprodol Tablets USP, 350 mg ......................................
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd.,
Cranbury, NJ 08512.
ANDA 040755 .........
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56977
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 062588 .........
Gentamicin Sulfate in 0.9% Sodium Chloride Injection,
Equivalent to (EQ) 1.2 mg base/milliliter (mL), EQ 1.4 mg
base/mL, EQ 1.6 mg base/mL, EQ 1.8 mg base/mL, EQ
2 mg base/mL, EQ 60 mg base/100 mL, EQ 70 mg
base/100 mL, EQ 80 mg base/100 mL, EQ 90 mg base/
100 mL, and EQ 100 mg base/100 mL.
Kefurox (cefuroxime) for Injection USP, EQ 750 mg base/
vial, EQ 1.5 grams (g) base/vial, and EQ 7.5 g base/vial.
Primaxin IV (imipenem and cilastatin) for Injection USP,
250 mg/vial; EQ 250 mg base/vial and 500 mg/vial; EQ
500 mg base/vial.
Cefazolin for Injection USP, EQ 1 g base/vial ......................
Hospira, Inc., a Pfizer Company, 275 North Field Dr., Bldg.
H1, Lake Forest, IL 60045.
ANDA 062591 .........
ANDA 062756 .........
ANDA 063207 .........
ANDA 063209 .........
ANDA 070195 .........
Cefazolin for Injection USP, EQ 10 g base/vial and EQ 20
g base/vial (Pharmacy Bulk Package).
Cefazolin for Injection USP, EQ 500 mg base/vial ...............
Amikacin Sulfate Injection USP, EQ 50 mg base/mL ...........
Ceftriaxone for Injection USP, EQ 1 g base/vial and EQ 2 g
base/vial.
Ceftriaxone for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package).
Cefotaxime for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package).
Cefoxitin for Injection USP, EQ 10 g base/vial (Pharmacy
Bulk Package).
Cefoxitin for Injection USP, EQ 1 g base/vial and EQ 2 g
base/vial.
Cotrim D.S. (sulfamethoxazole and trimethoprim) Tablets
USP, 800 mg/160 mg.
Valproic Acid Capsules USP, 250 mg ..................................
ANDA 070513 .........
Tolazamide Tablets USP, 100 mg ........................................
ANDA 070514 .........
ANDA 071358 .........
Tolazamide Tablets USP, 250 mg ........................................
Tolazamide Tablets USP, 250 mg ........................................
ANDA 071359 .........
ANDA 071667 .........
Tolazamide Tablets USP, 500 mg ........................................
Ibuprofen Tablets USP, 600 mg ............................................
ANDA 071668 .........
ANDA 071735 .........
Ibuprofen Tablets USP, 800 mg ............................................
Ibuprofen Tablets USP, 200 mg ............................................
ANDA 071773 .........
ANDA 073254 .........
ANDA 074075 .........
Ibuprofen Tablets USP, 200 mg ............................................
Loperamide Hydrochloride (HCl) Tablets USP, 2 mg ...........
Clemastine Fumarate Syrup, EQ 0.5 mg base/5 mL ............
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
Haloperidol Oral Solution USP, EQ 1 mg base/mL ..............
Ibuprofen Capsules, 200 mg .................................................
Naproxen Sodium Tablets USP, EQ 200 mg base ..............
Ibuprofen Tablets USP, 200 mg ............................................
Cimetidine Tablets USP, 200 mg ..........................................
Cimetidine Tablets USP, 200 mg ..........................................
Ranitidine Tablets USP, EQ 75 mg base .............................
Ibuprofen and Pseudoephedrine HCl Tablets USP, 200 mg/
30 mg.
Pantoprazole Sodium Delayed-Release Tablets USP, EQ
20 mg base and EQ 40 mg base.
Ondansetron Injection USP, EQ 2 mg base/mL ...................
Octreotide Acetate 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 ...............
Octreotide Acetate Injection, EQ 1 mg base/mL ..................
Sertraline HCl Tablets, EQ 25 mg base, EQ 50 mg base,
and EQ 100 mg base.
Torsemide Tablets, 5 mg, 10 mg, 20 mg, and 100 mg ........
Folic Acid Tablets, 1 mg ........................................................
ANDA 063214 .........
ANDA 063263 .........
ANDA 065268 .........
ANDA 065269 .........
ANDA 065348 .........
ANDA 065464 .........
ANDA 065467 .........
ANDA 070048 .........
074536
074782
074789
074931
074961
074963
075094
075588
.........
.........
.........
.........
.........
.........
.........
.........
ANDA 077058 .........
ANDA 077172 .........
ANDA 077329 .........
sradovich on DSK3GMQ082PROD with NOTICES
ANDA 077330 .........
ANDA 077331 .........
ANDA 078108 .........
ANDA 078478 .........
ANDA 083000 .........
ANDA 085549 .........
ANDA 086109 .........
ANDA 086577 .........
VerDate Sep<11>2014
Reserpine, Hydralazine HCl, and Hydrochlorothiazide Tablets, 0.1 mg/25 mg/15 mg.
Tolbutamide Tablets USP, 500 mg .......................................
Trimethobenzamide HCl Injection, 100 mg/mL .....................
16:44 Nov 30, 2017
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ACS Dobfar S.p.A., c/o Interchem Corp., 120 Route 17
North, Paramus, NJ 07652.
Merck Sharp & Dohme Corp., Subsidiary of Merck & Co.,
Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ
08889.
Facta Farmaceutici S.p.A., c/o Interchem Corp., 120 Route
17 North, Suite 115, Paramus, NJ 07652.
Do.
Do.
Hospira, Inc.
Facta Farmaceutici S.p.A.
Do.
Cephazone Pharma, LLC, 250 E. Bonita Ave., Pomona, CA
91767.
ACS Dobfar S.p.A.
Do.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham,
PA 19044.
Catalent Pharma Solutions, LLC, 2725 Scherer Dr. North,
St. Petersburg, FL 33716.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Sun Pharmaceutical Industries, Inc., 270 Prospect Plains
Rd., Cranbury, NJ 08512.
Do.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.,
425 Privet Rd., Horsham, PA 19044.
Do.
Contract Pharmacal Corp., c/o SciRegs International Inc.,
6333 Summercrest Dr., Columbia, MD 21045.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Contract Pharmacal Corp.
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Contract Pharmacal Corp.
Do.
Do.
Do.
Do.
Do.
Do.
Sun Pharmaceutical Industries, Ltd.
Do.
Do.
Do.
Do.
Do.
Do.
Ivax Pharmaceutical USA, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Do.
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Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
TABLE 1—Continued
Application No.
Drug
Applicant
ANDA 087191 .........
Triamcinolone Acetonide Lotion USP, 0.025% .....................
ANDA 087398 .........
ANDA 088229 .........
Spironolactone and Hydrochlorothiazide Tablets USP, 25
mg/25 mg.
Thioridazine HCl Oral Solution USP, 100 mg/mL .................
ANDA 088563 .........
Thioridazine HCl Tablets USP, 50 mg ..................................
ANDA 088567 .........
ANDA 088733 .........
ANDA 088869 .........
Thioridazine HCl Tablets USP, 25 mg ..................................
Meclizine HCl Tablets, 25 mg (Chewable) ............................
Thioridazine HCl Tablets USP, 150 mg ................................
ANDA 090800 .........
Quinapril Tablets USP, EQ 5 mg base, EQ 10 mg base,
EQ 20 mg base, and EQ 40 mg base.
Anastrozole Tablets, 1 mg ....................................................
Letrozole Tablets USP, 2.5 mg .............................................
Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/
0.035 mg, 0.75 mg/0.035 mg, and 1 mg/0.035 mg.
Alpharma U.S. Pharms, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Sun Pharmaceutical Industries, Ltd.
ANDA 091177 .........
ANDA 091466 .........
ANDA 200486 .........
ANDA 200488 .........
ANDA 200489 .........
ANDA 201250 .........
ANDA 201251 .........
ANDA 201828 .........
ANDA 202203 .........
ANDA 202746 .........
ANDA 202875 .........
ANDA 203476 .........
ANDA 203685 .........
ANDA 203838 .........
sradovich on DSK3GMQ082PROD with NOTICES
ANDA 203839 .........
Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/
0.035 mg.
Norethindrone and Ethinyl Estradiol Tablets USP, 1 mg/
0.035 mg.
Vancomycin HCl for Injection USP, EQ 5 g base/vial and
EQ 10 g base/vial (Pharmacy Bulk Package).
Vancomycin HCl for Injection USP, EQ 500 mg base/vial
and EQ 1 g base/vial.
Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03
mg.
Topotecan HCl for Injection, EQ 4 mg base/vial ..................
Zoledronic Acid Injection, EQ 4 mg base/5 mL ....................
Do.
Teva Pharmaceuticals USA, Inc.
Do.
Mylan Laboratories, Ltd.
Sun Pharmaceutical Industries, Ltd.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540.
Mylan Laboratories, Ltd.
Norgestrel and Ethinyl Estradiol Tablets USP, 0.5 mg/0.05
mg.
Zolmitriptan Tablets, 2.5 mg and 5 mg .................................
Irbesartan Tablets USP, 75 mg, 150 mg, and 300 mg .........
Sun Pharma Global FZE.
Ajanta Pharma Ltd., c/o Ajanta Pharma USA, Inc., One
Grande Commons, 440 US Highway 22 East, Suite 150,
Bridgewater, NJ 08807.
Tris Pharma, Inc., 2033 Route 130, Monmouth Junction, NJ
08852.
Hydrocodone Bitartrate, Chlorpheniramine Maleate, and
Pseudoephedrine HCl Oral Solution, 5 mg/4 mg/60 mg
per 5 mL.
Hydrocodone Bitartrate and Pseudoephedrine HCl Oral Solution, 5 mg/60 mg per 5 mL.
Therefore, approval of the
applications listed in table 1 of this
document, and all amendments and
supplements thereto, is hereby
withdrawn as of January 2, 2018.
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
Do.
Do.
Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
Do.
16:44 Nov 30, 2017
Jkt 244001
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Dated: November 27, 2017.
Leslie Kux,
Associate Commissioner for Policy..
[FR Doc. 2017–25920 Filed 11–30–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Teleconference
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS), Full
Committee Meeting.
Dates and Times:
Tuesday, January 9, 2018: 9:00 a.m.–
5:30 p.m. ET
PO 00000
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Wednesday, January 10, 2018: 8:45
a.m.–3:00 p.m. ET
Place: U.S. Department of Health and
Human Services, Hubert H. Humphrey
Building, 200 Independence Avenue
SW., Rm. 705A, Washington, DC 20201.
Status: Open.
Purpose: At the January 9–10, 2018
full meeting, the Committee will hear
presentations, hold discussions on
several health data policy topics and
begin work on activities outlined in the
NCVHS 2018 workplan. An
environmental scan report will be
reviewed and discussed by the full
Committee as part of the Health
Information Privacy and Security
Beyond HIPAA project. This effort
includes an exploration of challenges
that extend beyond HIPAA and the
range of policy options that may be
available to the Department related to
privacy, security and access measures to
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]]>Agencies
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)]
[Notices]
[Pages 56976-56978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25920]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6591]
Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 68 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: Approval is withdrawn as of January 2, 2018.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.
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
------------------------------------------------------------------------
ANDA 040135............... Estropipate Tablets Barr Laboratories,
USP, 0.75 milligrams Inc., Subsidiary of
(mg), 1.5 mg, and 3 Teva Pharmaceuticals
mg. USA, Inc., 425
Privet Rd., Horsham,
PA 19044.
ANDA 040755............... Carisoprodol Tablets Sun Pharmaceutical
USP, 350 mg. Industries, Ltd., c/
o Sun Pharmaceutical
Industries, Inc.,
270 Prospect Plains
Rd., Cranbury, NJ
08512.
[[Page 56977]]
ANDA 062588............... Gentamicin Sulfate in Hospira, Inc., a
0.9% Sodium Chloride Pfizer Company, 275
Injection, North Field Dr.,
Equivalent to (EQ) Bldg. H1, Lake
1.2 mg base/ Forest, IL 60045.
milliliter (mL), EQ
1.4 mg base/mL, EQ
1.6 mg base/mL, EQ
1.8 mg base/mL, EQ 2
mg base/mL, EQ 60 mg
base/100 mL, EQ 70
mg base/100 mL, EQ
80 mg base/100 mL,
EQ 90 mg base/100
mL, and EQ 100 mg
base/100 mL.
ANDA 062591............... Kefurox (cefuroxime) ACS Dobfar S.p.A., c/
for Injection USP, o Interchem Corp.,
EQ 750 mg base/vial, 120 Route 17 North,
EQ 1.5 grams (g) Paramus, NJ 07652.
base/vial, and EQ
7.5 g base/vial.
ANDA 062756............... Primaxin IV (imipenem Merck Sharp & Dohme
and cilastatin) for Corp., Subsidiary of
Injection USP, 250 Merck & Co., Inc., 1
mg/vial; EQ 250 mg Merck Dr., P.O. Box
base/vial and 500 mg/ 100, Whitehouse
vial; EQ 500 mg base/ Station, NJ 08889.
vial.
ANDA 063207............... Cefazolin for Facta Farmaceutici
Injection USP, EQ 1 S.p.A., c/o
g base/vial. Interchem Corp., 120
Route 17 North,
Suite 115, Paramus,
NJ 07652.
ANDA 063209............... Cefazolin for Do.
Injection USP, EQ 10
g base/vial and EQ
20 g base/vial
(Pharmacy Bulk
Package).
ANDA 063214............... Cefazolin for Do.
Injection USP, EQ
500 mg base/vial.
ANDA 063263............... Amikacin Sulfate Hospira, Inc.
Injection USP, EQ 50
mg base/mL.
ANDA 065268............... Ceftriaxone for Facta Farmaceutici
Injection USP, EQ 1 S.p.A.
g base/vial and EQ 2
g base/vial.
ANDA 065269............... Ceftriaxone for Do.
Injection USP, EQ 10
g base/vial
(Pharmacy Bulk
Package).
ANDA 065348............... Cefotaxime for Cephazone Pharma,
Injection USP, EQ 10 LLC, 250 E. Bonita
g base/vial Ave., Pomona, CA
(Pharmacy Bulk 91767.
Package).
ANDA 065464............... Cefoxitin for ACS Dobfar S.p.A.
Injection USP, EQ 10
g base/vial
(Pharmacy Bulk
Package).
ANDA 065467............... Cefoxitin for Do.
Injection USP, EQ 1
g base/vial and EQ 2
g base/vial.
ANDA 070048............... Cotrim D.S. Teva Pharmaceuticals
(sulfamethoxazole USA, Inc., 425
and trimethoprim) Privet Rd., Horsham,
Tablets USP, 800 mg/ PA 19044.
160 mg.
ANDA 070195............... Valproic Acid Catalent Pharma
Capsules USP, 250 mg. Solutions, LLC, 2725
Scherer Dr. North,
St. Petersburg, FL
33716.
ANDA 070513............... Tolazamide Tablets Watson Laboratories,
USP, 100 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425
Privet Rd., Horsham,
PA 19044.
ANDA 070514............... Tolazamide Tablets Do.
USP, 250 mg.
ANDA 071358............... Tolazamide Tablets Sun Pharmaceutical
USP, 250 mg. Industries, Inc.,
270 Prospect Plains
Rd., Cranbury, NJ
08512.
ANDA 071359............... Tolazamide Tablets Do.
USP, 500 mg.
ANDA 071667............... Ibuprofen Tablets Pliva, Inc.,
USP, 600 mg. Subsidiary of Teva
Pharmaceuticals USA,
Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 071668............... Ibuprofen Tablets Do.
USP, 800 mg.
ANDA 071735............... Ibuprofen Tablets Contract Pharmacal
USP, 200 mg. Corp., c/o SciRegs
International Inc.,
6333 Summercrest
Dr., Columbia, MD
21045.
ANDA 071773............... Ibuprofen Tablets Pliva, Inc.,
USP, 200 mg. Subsidiary of Teva
Pharmaceuticals USA,
Inc.
ANDA 073254............... Loperamide Contract Pharmacal
Hydrochloride (HCl) Corp.
Tablets USP, 2 mg.
ANDA 074075............... Clemastine Fumarate Actavis Mid Atlantic,
Syrup, EQ 0.5 mg LLC, Subsidiary of
base/5 mL. Teva Pharmaceuticals
USA, Inc., 425
Privet Rd., Horsham,
PA 19044.
ANDA 074536............... Haloperidol Oral Do.
Solution USP, EQ 1
mg base/mL.
ANDA 074782............... Ibuprofen Capsules, Contract Pharmacal
200 mg. Corp.
ANDA 074789............... Naproxen Sodium Do.
Tablets USP, EQ 200
mg base.
ANDA 074931............... Ibuprofen Tablets Do.
USP, 200 mg.
ANDA 074961............... Cimetidine Tablets Do.
USP, 200 mg.
ANDA 074963............... Cimetidine Tablets Do.
USP, 200 mg.
ANDA 075094............... Ranitidine Tablets Do.
USP, EQ 75 mg base.
ANDA 075588............... Ibuprofen and Do.
Pseudoephedrine HCl
Tablets USP, 200 mg/
30 mg.
ANDA 077058............... Pantoprazole Sodium Sun Pharmaceutical
Delayed-Release Industries, Ltd.
Tablets USP, EQ 20
mg base and EQ 40 mg
base.
ANDA 077172............... Ondansetron Injection Do.
USP, EQ 2 mg base/mL.
ANDA 077329............... Octreotide Acetate Do.
Injection, EQ 0.05
mg base/mL, EQ 0.1
mg base/mL, and EQ
0.5 mg base/mL.
ANDA 077330............... Octreotide Acetate Do.
Injection, EQ 0.2 mg
base/mL.
ANDA 077331............... Octreotide Acetate Do.
Injection, EQ 1 mg
base/mL.
ANDA 078108............... Sertraline HCl Do.
Tablets, EQ 25 mg
base, EQ 50 mg base,
and EQ 100 mg base.
ANDA 078478............... Torsemide Tablets, 5 Do.
mg, 10 mg, 20 mg,
and 100 mg.
ANDA 083000............... Folic Acid Tablets, 1 Ivax Pharmaceutical
mg. USA, Inc.,
Subsidiary of Teva
Pharmaceuticals USA,
Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 085549............... Reserpine, Watson Laboratories,
Hydralazine HCl, and Inc., Subsidiary of
Hydrochlorothiazide Teva Pharmaceuticals
Tablets, 0.1 mg/25 USA, Inc.
mg/15 mg.
ANDA 086109............... Tolbutamide Tablets Do.
USP, 500 mg.
ANDA 086577............... Trimethobenzamide HCl Do.
Injection, 100 mg/mL.
[[Page 56978]]
ANDA 087191............... Triamcinolone Alpharma U.S. Pharms,
Acetonide Lotion Subsidiary of Teva
USP, 0.025%. Pharmaceuticals USA,
Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 087398............... Spironolactone and Watson Laboratories,
Hydrochlorothiazide Inc., Subsidiary of
Tablets USP, 25 mg/ Teva Pharmaceuticals
25 mg. USA, Inc.
ANDA 088229............... Thioridazine HCl Oral Actavis Mid Atlantic,
Solution USP, 100 mg/ LLC, Subsidiary of
mL. Teva Pharmaceuticals
USA, Inc.
ANDA 088563............... Thioridazine HCl Watson Laboratories,
Tablets USP, 50 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 088567............... Thioridazine HCl Do.
Tablets USP, 25 mg.
ANDA 088733............... Meclizine HCl Pliva, Inc.,
Tablets, 25 mg Subsidiary of Teva
(Chewable). Pharmaceuticals USA,
Inc.
ANDA 088869............... Thioridazine HCl Watson Laboratories,
Tablets USP, 150 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 090800............... Quinapril Tablets Sun Pharmaceutical
USP, EQ 5 mg base, Industries, Ltd.
EQ 10 mg base, EQ 20
mg base, and EQ 40
mg base.
ANDA 091177............... Anastrozole Tablets, Do.
1 mg.
ANDA 091466............... Letrozole Tablets Do.
USP, 2.5 mg.
ANDA 200486............... Norethindrone and Mylan Laboratories,
Ethinyl Estradiol Ltd., c/o Mylan
Tablets USP, 0.5 mg/ Pharmaceuticals,
0.035 mg, 0.75 mg/ Inc., 781 Chestnut
0.035 mg, and 1 mg/ Ridge Rd., P.O. Box
0.035 mg. 4310, Morgantown, WV
26504.
ANDA 200488............... Norethindrone and Do.
Ethinyl Estradiol
Tablets USP, 0.5 mg/
0.035 mg.
ANDA 200489............... Norethindrone and Do.
Ethinyl Estradiol
Tablets USP, 1 mg/
0.035 mg.
ANDA 201250............... Vancomycin HCl for Teva Pharmaceuticals
Injection USP, EQ 5 USA, Inc.
g base/vial and EQ
10 g base/vial
(Pharmacy Bulk
Package).
ANDA 201251............... Vancomycin HCl for Do.
Injection USP, EQ
500 mg base/vial and
EQ 1 g base/vial.
ANDA 201828............... Norgestrel and Mylan Laboratories,
Ethinyl Estradiol Ltd.
Tablets USP, 0.3 mg/
0.03 mg.
ANDA 202203............... Topotecan HCl for Sun Pharmaceutical
Injection, EQ 4 mg Industries, Ltd.
base/vial.
ANDA 202746............... Zoledronic Acid Sun Pharma Global
Injection, EQ 4 mg FZE, c/o Sun
base/5 mL. Pharmaceutical
Industries, Inc., 2
Independence Way,
Princeton, NJ 08540.
ANDA 202875............... Norgestrel and Mylan Laboratories,
Ethinyl Estradiol Ltd.
Tablets USP, 0.5 mg/
0.05 mg.
ANDA 203476............... Zolmitriptan Tablets, Sun Pharma Global
2.5 mg and 5 mg. FZE.
ANDA 203685............... Irbesartan Tablets Ajanta Pharma Ltd., c/
USP, 75 mg, 150 mg, o Ajanta Pharma USA,
and 300 mg. Inc., One Grande
Commons, 440 US
Highway 22 East,
Suite 150,
Bridgewater, NJ
08807.
ANDA 203838............... Hydrocodone Tris Pharma, Inc.,
Bitartrate, 2033 Route 130,
Chlorpheniramine Monmouth Junction,
Maleate, and NJ 08852.
Pseudoephedrine HCl
Oral Solution, 5 mg/
4 mg/60 mg per 5 mL.
ANDA 203839............... Hydrocodone Do.
Bitartrate and
Pseudoephedrine HCl
Oral Solution, 5 mg/
60 mg per 5 mL.
------------------------------------------------------------------------
Therefore, approval of the applications listed in table 1 of this
document, and all amendments and supplements thereto, is hereby
withdrawn as of January 2, 2018. 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: November 27, 2017.
Leslie Kux,
Associate Commissioner for Policy..
[FR Doc. 2017-25920 Filed 11-30-17; 8:45 am]
BILLING CODE 4164-01-P
