Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85 Abbreviated New Drug Applications, 40850-40851 [2021-16178]
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40850
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0554]
Actavis Elizabeth LLC, et al.;
Withdrawal of Approval of 85
Abbreviated New Drug Applications
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described 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:
Application No.
Drug
Applicant
ANDA 040113 ....
Chlorzoxazone Tablets, 500 milligrams (mg) ..........................
ANDA 040152 ....
Carisoprodol Tablets, 350 mg ..................................................
ANDA
ANDA
ANDA
ANDA
....
....
....
....
Trihexyphenidyl Hydrochloride (HCl) Tablets, 2 mg and 5 mg
Estradiol Tablets, 0.5 mg, 1 mg, 1.5 mg, and 2 mg ................
Phentermine HCl Tablets, 37.5 mg .........................................
Estropipate Tablets, 0.75 mg, 1.5 mg, and 3 mg ....................
ANDA 060704 ....
Tetracycline HCl Capsules, 250 mg and 500 mg ....................
ANDA 062343 ....
ANDA 062581 ....
....
....
....
....
....
....
....
....
....
....
....
....
....
Tetracycline HCl Capsules, 250 mg and 500 mg ....................
Doxycycline Hyclate Tablets, Equivalent to (EQ) 100 mg
base.
Diazepam Tablets, 2 mg ..........................................................
Diazepam Tablets, 5 mg ..........................................................
Diazepam Tablets, 10 mg ........................................................
Metoclopramide HCl Tablets, EQ 10 mg base ........................
Propranolol HCl Tablets, 10 mg ..............................................
Diazepam Tablets, 5 mg ..........................................................
Diazepam Tablets, 10 mg ........................................................
Diazepam Tablets, 2 mg ..........................................................
Verapamil HCl Tablets, 120 mg ...............................................
Oxazepam Capsules, 15 mg ...................................................
Clonidine HCl Tablets, 0.2 mg .................................................
Clonidine HCI Tablets, 0.1 mg .................................................
Ibuprofen Tablets, 200 mg .......................................................
ANDA 071019 ....
ANDA 071050 ....
Verapamil HCl Tablets, 80 mg .................................................
Morphine Sulfate Injection, 0.5 mg/milliliters (mL) ...................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
....
....
....
....
....
....
....
....
Lorazepam Tablets, 0.5 mg .....................................................
Lorazepam Tablets, 1 mg ........................................................
Lorazepam Tablets, 2 mg ........................................................
Verapamil HCl Tablets, 80 mg .................................................
Verapamil HCl Tablets, 120 mg ...............................................
Betamethasone Dipropionate Cream, EQ 0.05% base ...........
Betamethasone Dipropionate Ointment, EQ 0.05% base .......
Carbamazepine Tablets, 200 mg .............................................
ANDA 071696 ....
ANDA 071969 ....
Carbamazepine Tablets, 200 mg .............................................
Triamterene and Hydrochlorothiazide Tablets, 50 mg and 75
mg.
Verapamil HCl Tablets, 80 mg .................................................
Verapamil HCl Tablets, 120 mg ...............................................
Prazosin HCl Capsules, EQ 2 mg base ..................................
Prazosin HCl Capsules, EQ 1 mg base ..................................
Amoxapine Tablets, 25 mg ......................................................
Amoxapine Tablets, 50 mg ......................................................
Actavis Elizabeth LLC (an indirect, wholly owned subsidiary
of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy.,
Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Building A, Parsippany, NJ 07054.
Do.
Do.
Actavis Elizabeth LLC.
Barr Laboratories, Inc. (an indirect, wholly owned subsidiary
of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy.,
Building A, Parsippany, NJ 07054.
Ivax Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Barr Laboratories, Inc.
Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc.
Watson Laboratories, Inc.
Do.
Actavis Elizabeth LLC.
Do.
Do.
Watson Laboratories, Inc.
Ivax Pharmaceuticals, Inc.
Watson Laboratories, Inc.
Do.
Merro Pharmaceutical Co., Ltd., SciRegs International, Inc.,
Authorized U.S. Agent, 6333 Summercrest Dr., Columbia,
MD 21045.
Actavis Elizabeth LLC.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
Watson Laboratories, Inc.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
PLIVA Inc. (an indirect, wholly owned subsidiary of Teva
Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building
A, Parsippany, NJ 07054.
Actavis Elizabeth LLC.
Watson Laboratories, Inc.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
jbell on DSKJLSW7X2PROD with NOTICES
withdrawing approval of 85 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
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
August 30, 2021.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
040184
040212
040276
040296
070152
070153
070154
070511
070548
070706
070707
070781
070856
070944
070964
070965
070985
071086
071087
071088
071366
071367
071476
071477
071479
072124
072125
072333
072352
072418
072419
VerDate Sep<11>2014
....
....
....
....
....
....
19:19 Jul 28, 2021
Jkt 253001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
PLIVA Inc.
Do.
Watson Laboratories, Inc.
Do.
Do.
Do.
E:\FR\FM\29JYN1.SGM
29JYN1
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
Application No.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
072420
072421
072609
072751
072923
072953
072954
073093
073122
073334
....
....
....
....
....
....
....
....
....
....
ANDA
ANDA
ANDA
ANDA
ANDA
073352
073353
073637
073638
074026
....
....
....
....
....
ANDA 074359 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
074405
074421
074436
074442
074479
074647
074762
074836
074892
074955
074964
075067
....
....
....
....
....
....
....
....
....
....
....
....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
075069
075262
075284
081165
084503
085054
085084
085085
085208
086710
....
....
....
....
....
....
....
....
....
....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
086813
087773
088348
088349
088350
088497
....
....
....
....
....
....
jbell on DSKJLSW7X2PROD with NOTICES
ANDA 089536 ....
Drug
VerDate Sep<11>2014
Applicant
Amoxapine Tablets, 100 mg ....................................................
Amoxapine Tablets, 150 mg ....................................................
Prazosin HCl Capsules, EQ 5 mg base ..................................
Verapamil HCl Tablets, 40 mg .................................................
Verapamil HCl Tablets, 40 mg .................................................
Oxazepam Capsules, 15 mg ...................................................
Oxazepam Capsules, 30 mg ...................................................
Baclofen Tablets, 20 mg ..........................................................
Loperamide HCl Capsules, 2 mg .............................................
Amiloride HCl and Hydrochlorothiazide Tablets, EQ 5 mg anhydrous; 50 mg.
Atenolol Tablets, 50 mg ...........................................................
Atenolol Tablets, 100 mg .........................................................
Piroxicam Capsules, 10 mg .....................................................
Piroxicam Capsules, 20 mg .....................................................
Triamterene and Hydrochlorothiazide Tablets, 25 mg and
37.5 mg.
Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mg.
Flurbiprofen Tablets, 50 mg and 100 mg ................................
Cyclobenzaprine HCl Tablets, 10 mg ......................................
Cyclobenzaprine HCl Tablets, 10 mg ......................................
Gemfibrozil Tablets, 600 mg ....................................................
Alprazolam Tablets, 0.25 mg, 0.5 mg, and 1 mg ....................
Flurbiprofen Tablets, 50 mg and 100 mg ................................
Guanfacine HCl Tablets, EQ 1 mg base and EQ 2 mg base
Acyclovir Tablets, 400 mg and 800 mg ...................................
Etodolac Tablets, 400 mg and 500 mg ...................................
Ketorolac Tromethamine Tablets, 10 mg ................................
Clonazepam Tablets, 0.5 mg, 1 mg, and 2 mg .......................
Cromolyn Sodium Inhalation Solution, 10 mg/mL ...................
Etodolac Tablets, 400 mg ........................................................
Albuterol Sulfate Syrup, EQ 2 mg base/5 mL .........................
Ketorolac Tromethamine Tablets, 10 mg ................................
Hydroxyzine Pamoate Capsules, EQ 25 mg HCl ....................
Hydralazine HCl Tablets, 50 mg ..............................................
Hydrochlorothiazide Tablets, 25 mg ........................................
Prednisone Tablets, 5 mg ........................................................
Prednisolone Tablets, 5 mg .....................................................
Hydrochlorothiazide Tablets, 50 mg ........................................
Aspirin, Butalbital, Caffeine Tablets, 325 mg, 50 mg, and 40
mg.
Prednisone Tablets, 20 mg ......................................................
Prednisone Tablets, 10 mg ......................................................
Hydroxyzine HCl Tablets, 10 mg .............................................
Hydroxyzine HCl Tablets, 25 mg .............................................
Hydroxyzine HCl Tablets, 50 mg .............................................
Methylprednisolone Tablets, 4 mg ...........................................
Acetaminophen, Butalbital, and Caffeine Tablets, 325 mg, 50
mg, and 40 mg.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of August 30,
2021. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
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 the table
19:19 Jul 28, 2021
Jkt 253001
Do.
Do.
Do.
PLIVA Inc.
Watson Laboratories, Inc.
Do.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
PLIVA Inc.
Watson Laboratories, Inc.
Teva Pharmaceuticals USA, Inc.
PLIVA Inc.
Watson Laboratories, Inc.
Do.
Do.
PLIVA Inc.
Watson Laboratories, Inc.
IVAX Pharmaceuticals, Inc.
Watson Laboratories, Inc.
Do.
Do.
Actavis Mid Atlantic LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace
Pkwy., Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
Actavis Mid Atlantic LLC.
PLIVA Inc.
Watson Laboratories, Inc.
Do.
Actavis Mid Atlantic LLC.
Watson Laboratories, Inc.
Do.
Actavis Elizabeth LLC.
Do.
Watson Laboratories, Inc.
Do.
Do.
Do.
Do.
Duramed Pharmaceuticals Inc. (an indirect wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc.), 400
Interpace Pkwy., Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
that are in inventory on August 30, 2021
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: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16178 Filed 7–28–21; 8:45 am]
BILLING CODE 4164–01–P
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40851
Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0519]
Rabies: Developing Monoclonal
Antibody Cocktails for the Passive
Immunization Component of PostExposure Prophylaxis; Draft Guidance
for Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40850-40851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16178]
[[Page 40850]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0554]
Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 85 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants 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 August 30, 2021.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040113............ Chlorzoxazone Tablets, Actavis Elizabeth LLC
500 milligrams (mg). (an indirect, wholly
owned subsidiary of
Teva Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ 07054.
ANDA 040152............ Carisoprodol Tablets, Watson Laboratories,
350 mg. Inc. (an indirect,
wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Pkwy., Building A,
Parsippany, NJ 07054.
ANDA 040184............ Trihexyphenidyl Do.
Hydrochloride (HCl)
Tablets, 2 mg and 5 mg.
ANDA 040212............ Estradiol Tablets, 0.5 Do.
mg, 1 mg, 1.5 mg, and
2 mg.
ANDA 040276............ Phentermine HCl Actavis Elizabeth LLC.
Tablets, 37.5 mg.
ANDA 040296............ Estropipate Tablets, Barr Laboratories,
0.75 mg, 1.5 mg, and 3 Inc. (an indirect,
mg. wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Pkwy., Building A,
Parsippany, NJ 07054.
ANDA 060704............ Tetracycline HCl Ivax Pharmaceuticals,
Capsules, 250 mg and Inc. (an indirect,
500 mg. wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Pkwy., Building A,
Parsippany, NJ 07054.
ANDA 062343............ Tetracycline HCl Watson Laboratories,
Capsules, 250 mg and Inc.
500 mg.
ANDA 062581............ Doxycycline Hyclate Teva Pharmaceuticals
Tablets, Equivalent to USA, Inc., 400
(EQ) 100 mg base. Interpace Pkwy.,
Building A,
Parsippany, NJ 07054.
ANDA 070152............ Diazepam Tablets, 2 mg. Barr Laboratories,
Inc.
ANDA 070153............ Diazepam Tablets, 5 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 070154............ Diazepam Tablets, 10 mg Barr Laboratories,
Inc.
ANDA 070511............ Metoclopramide HCl Watson Laboratories,
Tablets, EQ 10 mg base. Inc.
ANDA 070548............ Propranolol HCl Do.
Tablets, 10 mg.
ANDA 070706............ Diazepam Tablets, 5 mg. Actavis Elizabeth LLC.
ANDA 070707............ Diazepam Tablets, 10 mg Do.
ANDA 070781............ Diazepam Tablets, 2 mg. Do.
ANDA 070856............ Verapamil HCl Tablets, Watson Laboratories,
120 mg. Inc.
ANDA 070944............ Oxazepam Capsules, 15 Ivax Pharmaceuticals,
mg. Inc.
ANDA 070964............ Clonidine HCl Tablets, Watson Laboratories,
0.2 mg. Inc.
ANDA 070965............ Clonidine HCI Tablets, Do.
0.1 mg.
ANDA 070985............ Ibuprofen Tablets, 200 Merro Pharmaceutical
mg. Co., Ltd., SciRegs
International, Inc.,
Authorized U.S.
Agent, 6333
Summercrest Dr.,
Columbia, MD 21045.
ANDA 071019............ Verapamil HCl Tablets, Actavis Elizabeth LLC.
80 mg.
ANDA 071050............ Morphine Sulfate Fresenius Kabi USA,
Injection, 0.5 mg/ LLC, Three Corporate
milliliters (mL). Dr., Lake Zurich, IL
60047.
ANDA 071086............ Lorazepam Tablets, 0.5 Watson Laboratories,
mg. Inc.
ANDA 071087............ Lorazepam Tablets, 1 mg Do.
ANDA 071088............ Lorazepam Tablets, 2 mg Do.
ANDA 071366............ Verapamil HCl Tablets, Do.
80 mg.
ANDA 071367............ Verapamil HCl Tablets, Do.
120 mg.
ANDA 071476............ Betamethasone Teva Pharmaceuticals
Dipropionate Cream, EQ USA, Inc.
0.05% base.
ANDA 071477............ Betamethasone Do.
Dipropionate Ointment,
EQ 0.05% base.
ANDA 071479............ Carbamazepine Tablets, PLIVA Inc. (an
200 mg. indirect, wholly
owned subsidiary of
Teva Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ 07054.
ANDA 071696............ Carbamazepine Tablets, Actavis Elizabeth LLC.
200 mg.
ANDA 071969............ Triamterene and Watson Laboratories,
Hydrochlorothiazide Inc.
Tablets, 50 mg and 75
mg.
ANDA 072124............ Verapamil HCl Tablets, PLIVA Inc.
80 mg.
ANDA 072125............ Verapamil HCl Tablets, Do.
120 mg.
ANDA 072333............ Prazosin HCl Capsules, Watson Laboratories,
EQ 2 mg base. Inc.
ANDA 072352............ Prazosin HCl Capsules, Do.
EQ 1 mg base.
ANDA 072418............ Amoxapine Tablets, 25 Do.
mg.
ANDA 072419............ Amoxapine Tablets, 50 Do.
mg.
[[Page 40851]]
ANDA 072420............ Amoxapine Tablets, 100 Do.
mg.
ANDA 072421............ Amoxapine Tablets, 150 Do.
mg.
ANDA 072609............ Prazosin HCl Capsules, Do.
EQ 5 mg base.
ANDA 072751............ Verapamil HCl Tablets, PLIVA Inc.
40 mg.
ANDA 072923............ Verapamil HCl Tablets, Watson Laboratories,
40 mg. Inc.
ANDA 072953............ Oxazepam Capsules, 15 Do.
mg.
ANDA 072954............ Oxazepam Capsules, 30 Do.
mg.
ANDA 073093............ Baclofen Tablets, 20 mg Do.
ANDA 073122............ Loperamide HCl Teva Pharmaceuticals
Capsules, 2 mg. USA, Inc.
ANDA 073334............ Amiloride HCl and Watson Laboratories,
Hydrochlorothiazide Inc.
Tablets, EQ 5 mg
anhydrous; 50 mg.
ANDA 073352............ Atenolol Tablets, 50 mg Do.
ANDA 073353............ Atenolol Tablets, 100 Do.
mg.
ANDA 073637............ Piroxicam Capsules, 10 Teva Pharmaceuticals
mg. USA, Inc.
ANDA 073638............ Piroxicam Capsules, 20 Do.
mg.
ANDA 074026............ Triamterene and PLIVA Inc.
Hydrochlorothiazide
Tablets, 25 mg and
37.5 mg.
ANDA 074359............ Butalbital, Aspirin, Watson Laboratories,
Caffeine, and Codeine Inc.
Phosphate Capsules,
325 mg, 50 mg, 40 mg,
and 30 mg.
ANDA 074405............ Flurbiprofen Tablets, Teva Pharmaceuticals
50 mg and 100 mg. USA, Inc.
ANDA 074421............ Cyclobenzaprine HCl PLIVA Inc.
Tablets, 10 mg.
ANDA 074436............ Cyclobenzaprine HCl Watson Laboratories,
Tablets, 10 mg. Inc.
ANDA 074442............ Gemfibrozil Tablets, Do.
600 mg.
ANDA 074479............ Alprazolam Tablets, Do.
0.25 mg, 0.5 mg, and 1
mg.
ANDA 074647............ Flurbiprofen Tablets, PLIVA Inc.
50 mg and 100 mg.
ANDA 074762............ Guanfacine HCl Tablets, Watson Laboratories,
EQ 1 mg base and EQ 2 Inc.
mg base.
ANDA 074836............ Acyclovir Tablets, 400 IVAX Pharmaceuticals,
mg and 800 mg. Inc.
ANDA 074892............ Etodolac Tablets, 400 Watson Laboratories,
mg and 500 mg. Inc.
ANDA 074955............ Ketorolac Tromethamine Do.
Tablets, 10 mg.
ANDA 074964............ Clonazepam Tablets, 0.5 Do.
mg, 1 mg, and 2 mg.
ANDA 075067............ Cromolyn Sodium Actavis Mid Atlantic
Inhalation Solution, LLC (an indirect,
10 mg/mL. wholly owned
subsidiary of Teva
Pharmaceuticals USA,
Inc.), 400 Interpace
Pkwy., Building A,
Parsippany, NJ 07054.
ANDA 075069............ Etodolac Tablets, 400 Watson Laboratories,
mg. Inc.
ANDA 075262............ Albuterol Sulfate Actavis Mid Atlantic
Syrup, EQ 2 mg base/5 LLC.
mL.
ANDA 075284............ Ketorolac Tromethamine PLIVA Inc.
Tablets, 10 mg.
ANDA 081165............ Hydroxyzine Pamoate Watson Laboratories,
Capsules, EQ 25 mg HCl. Inc.
ANDA 084503............ Hydralazine HCl Do.
Tablets, 50 mg.
ANDA 085054............ Hydrochlorothiazide Actavis Mid Atlantic
Tablets, 25 mg. LLC.
ANDA 085084............ Prednisone Tablets, 5 Watson Laboratories,
mg. Inc.
ANDA 085085............ Prednisolone Tablets, 5 Do.
mg.
ANDA 085208............ Hydrochlorothiazide Actavis Elizabeth LLC.
Tablets, 50 mg.
ANDA 086710............ Aspirin, Butalbital, Do.
Caffeine Tablets, 325
mg, 50 mg, and 40 mg.
ANDA 086813............ Prednisone Tablets, 20 Watson Laboratories,
mg. Inc.
ANDA 087773............ Prednisone Tablets, 10 Do.
mg.
ANDA 088348............ Hydroxyzine HCl Do.
Tablets, 10 mg.
ANDA 088349............ Hydroxyzine HCl Do.
Tablets, 25 mg.
ANDA 088350............ Hydroxyzine HCl Do.
Tablets, 50 mg.
ANDA 088497............ Methylprednisolone Duramed
Tablets, 4 mg. Pharmaceuticals Inc.
(an indirect wholly
owned subsidiary of
Teva Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Building A,
Parsippany, NJ 07054.
ANDA 089536............ Acetaminophen, Watson Laboratories,
Butalbital, and Inc.
Caffeine Tablets, 325
mg, 50 mg, and 40 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 30, 2021. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. 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 the table that
are in inventory on August 30, 2021 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: July 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16178 Filed 7-28-21; 8:45 am]
BILLING CODE 4164-01-P
