CDER New: 8/11/2021

What's New Related to Drugs Updated Monday through Friday: Drug Firm Annual Registration Status Drug Firm Annual Registration Status Download File National Drug Code Directory NDC Unfinished Drugs Excluded Database File NDC Database Excluded Packages and Products Wholesale Distributor and Third-Party Logistics Providers Reporting August 10, 2021 Drugs@FDA Data Files (updated) FDA Drug Shortages Piroxicam Capsules (New - Discontinuation) KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature Abuse Recent New and Generic Drug Approvals This report displays final approvals and tentative approvals of original and supplemental applications for the two days beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this time span. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA. August 10, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Brilinta NDA #022433 Ticagrelor Tablet; Oral SUPPL-32 Astrazeneca Labeling Approved August 9, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Glycopyrrolate ANDA #204438 Glycopyrrolate Solution; Oral ORIG-1 Par Pharm Inc   Approved Evomela NDA #207155 Melphalan Hydrochloride Powder; Intravenous SUPPL-4 Acrotech Labeling Approved Difluprednate ANDA #211776 Difluprednate Emulsion; Ophthalmic ORIG-1 Cipla   Approved Memantine Hydrochloride ANDA #214651 Memantine Hydrochloride Capsule, Extended Release; Oral ORIG-1 Aurobindo Pharma Ltd   Approved Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA