CDER New: 1/12/2021

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 January 11, 2021 Drug Trials Snapshot: GEMTESA FDA Drug Shortages Tacrolimus Capsules (Updated - Currently in Shortage) Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter 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. January 8, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Bivalirudin In 0.9% Sodium Chloride NDA #208374 Bivalirudin Solution; Intravenous SUPPL-2 Baxter Hlthcare Corp Labeling Approved Pemetrexed NDA #208746 Pemetrexed Unknown ORIG-1 Hospira Inc Type 3 - New Dosage Form Tentative Approval January 7, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Caduet NDA #021540 Amlodipine Besylate; Atorvastatin Calcium Tablet; Oral SUPPL-46 Pharmacia Labeling Approved Children's Claritin NDA #021891 Loratadine Tablet, Chewable; Oral SUPPL-36 Bayer Healthcare Llc Labeling Approved Claritin NDA #021891 Loratadine Tablet, Chewable; Oral SUPPL-36 Bayer Healthcare Llc Labeling Approved Azathioprine Sodium ANDA #074419 Azathioprine Sodium Injectable; Injection SUPPL-15 West-Ward Pharms Int Labeling Approved Bromocriptine Mesylate ANDA #074631 Bromocriptine Mesylate Tablet; Oral SUPPL-10 Sandoz Inc Labeling Approved Mirtazapine ANDA #077666 Mirtazapine Tablet; Oral SUPPL-14 Apotex Inc Labeling Approved Tadalafil ANDA #211335 Tadalafil Tablet; Oral SUPPL-2 Sunshine Labeling Approved Tadalafil ANDA #211335 Tadalafil Tablet; Oral SUPPL-2 Sunshine Labeling Approved Nubeqa NDA #212099 Darolutamide Tablet; Oral SUPPL-1 Bayer Healthcare Efficacy Approved Pentamidine Isethionate ANDA #213806 Pentamidine Isethionate Injectable; Injection ORIG-1 Emcure Pharms Ltd   Approved Fluphenazine Hydrochloride ANDA #214534 Fluphenazine Hydrochloride Tablet; Oral ORIG-1 Cerovene Inc   Approved Loratadine ANDA #214684 Loratadine Tablet; Oral ORIG-1 Unique Pharm   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