Federal Register - July 29, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices Application No.
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jbell on DSKJLSW7X2PROD with NOTICES
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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Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of August 30, 2021. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table.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 301a and d of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 331a and d.
Drug products that are listed in the table
19:19 Jul 28, 2021
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Do.
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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. 202116178 Filed 72821; 8:45 am BILLING CODE 416401P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021D0519
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:FRFM29JYN1.SGM
29JYN1
