CDER New: 12/1/2021

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 November 30, 2021 Drugs@FDA Data Files (updated) FDA Drug Shortages Amphetamine Oral Suspension, Extended Release (New - Currently in Shortage) Betamethasone Valerate Topical Foam (New - Discontinuation) Clonidine Hydrochloride Extended Release Tablets (New - Discontinuation) Febuxostat Tablets (New - Discontinuation) Sterile Water for Injection (New - Currently in Shortage) Generic Drug Research Priorities & Projects (updated) 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. November 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Ribavirin ANDA #076277 Ribavirin Capsule; Oral SUPPL-13 Teva Labeling Approved Ribavirin ANDA #076277 Ribavirin Capsule; Oral SUPPL-13 Teva Labeling Approved Fenofibric Acid ANDA #200750 Choline Fenofibrate Capsule, Delayed Release; Oral SUPPL-16 Lupin Ltd Labeling Approved Lumify NDA #208144 Brimonidine Tartrate Solution/Drops; Ophthalmic SUPPL-13 Bausch and Lomb Inc Labeling Approved Miglustat ANDA #208342 Miglustat Capsule; Oral SUPPL-3 Ani Pharms Labeling Approved Miglustat ANDA #208342 Miglustat Capsule; Oral SUPPL-3 Ani Pharms Labeling Approved Chlorpromazine Hydrochloride ANDA #212630 Chlorpromazine Hydrochloride Tablet; Oral ORIG-1 Enaltec   Approved Mycophenolic Acid ANDA #214630 Mycophenolic Acid Tablet, Delayed Release; Oral ORIG-1 Biocon Pharma   Approved Cytalux NDA #214907 Pafolacianine Injectable; Injection ORIG-1 On Target Labrotories, Inc. Type 1 - New Molecular Entity Approved November 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Intron A BLA #103132 Interferon Alfa-2b Vial SUPPL-5202 Schering Labeling Approved Everolimus ANDA #214138 Everolimus Tablet; Oral ORIG-1 Alkem Labs Ltd   Approved Detroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #214403 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Capsule, Extended Release; Oral ORIG-1 Lannett Co Inc   Approved Daptomycin ANDA #215215 Daptomycin Powder; Intravenous ORIG-1 Hangzhou Zhongmei   Approved Atropine Sulfate ANDA #215624 Atropine Sulfate Solution/Drops; Ophthalmic ORIG-1 Apotex Inc   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