CDER New: 1/22/2021

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 21, 2021 FDA Drug Shortages Amoxapine Tablets (Updated - Currently in Shortage) Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets (Updated - Currently in Shortage) Bupivacaine Hydrochloride and Epinephrine Injection, USP (Updated - Currently in Shortage) Cefotetan Disodium Injection (Updated - Currently in Shortage) Cisatracurium Besylate Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Dexmedetomidine Injection (Updated - Currently in Shortage) Famotidine Injection (Updated - Currently in Shortage) Famotidine Tablets (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Fluorescein Strips (Updated - Currently in Shortage) Furosemide Injection, USP (Updated - Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Updated - Currently in Shortage) Ketorolac Tromethamine Injection (Updated - Currently in Shortage) Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Updated - Currently in Shortage) Loxapine Capsules (Updated - Currently in Shortage) Midazolam Injection, USP (Updated - Currently in Shortage) Morphine Sulfate Injection, USP (Currently in Shortage) Ondansetron Hydrochloride Injection (Updated - Currently in Shortage) Oxytocin Injection, USP Synthetic (Updated - Currently in Shortage) Ropivacaine Hydrochloride Injection (Updated - Currently in Shortage) Sodium Chloride 23.4% Injection (Updated - Currently in Shortage) Sodium Chloride Injection USP, 0.9% Vials and Syringes (Updated - Currently in Shortage) Tacrolimus Capsules (Updated - Currently in Shortage) Timolol Maleate Tablets (Updated - Resolved) Tobramycin Lyophilized Powder for Injection (Updated - Currently in Shortage) Trifluridine Ophthalmic Solution (Updated - Resolved) 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 21, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Edurant NDA #202022 Rilpivirine Hydrochloride Tablet; Oral SUPPL-14 Janssen Prods Efficacy Approved January 19, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Faslodex NDA #021344 Fulvestrant Injectable; Intramuscular SUPPL-44 Astrazeneca Labeling Approved Bromocriptine Mesylate ANDA #078899 Bromocriptine Mesylate Capsule; Oral SUPPL-7 Zydus Pharms Usa Inc Labeling Approved Fludeoxyglucose F18 ANDA #203709 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-4 Wisconsin Labeling Approved Fludeoxyglucose F18 ANDA #203710 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-1 Biomedcl Res Fdn Labeling Approved Bloxiverz NDA #204078 Neostigmine Methylsulfate Solution; Intravenous SUPPL-10 Exela Pharma Labeling Approved Spritam NDA #207958 Levetiracetam Tablet, For Suspension; Oral SUPPL-19 Aprecia Pharms Efficacy Approved Fingolimod Hydrochloride ANDA #208005 Fingolimod Hydrochloride Capsule; Oral ORIG-1 Mylan   Approved Lamotrigine ANDA #213271 Lamotrigine Tablet, Orally Disintegrating; Oral ORIG-1 Ajanta Pharma Ltd   Approved Verquvo NDA #214377 Vericiguat Tablet; Oral ORIG-1 Merck Sharp Dohme Type 1 - New Molecular Entity 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