CDER New: 12/30/2021

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 December 29, 2021 Questions and Answers: Integration of FDA Facility Evaluation and Inspection Program for Human Drugs (updated) Drug Shortages (12/28/2021) Amino Acids (Updated - Currently in Shortage) Atropine Sulfate Injection (Updated - Currently in Shortage) Cefazolin Injection (Updated - Currently in Shortage) Sodium Chloride 0.9% Injection Bags (Updated - Currently in Shortage) 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. December 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cabazitaxel NDA #207949 Cabazitaxel Injectable; Injection ORIG-1 Accord Hlthcare Inc Type 5 - New Formulation or New Manufacturer Approved Calcium Gluconate NDA #208418 Calcium Gluconate Solution; Intravenous SUPPL-11 Fresenius Kabi Usa Labeling Approved Calcium Gluconate In Sodium Chloride NDA #208418 Calcium Gluconate Solution; Intravenous SUPPL-11 Fresenius Kabi Usa Labeling Approved December 28, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Eovist NDA #022090 Gadoxetate Disodium Solution; Intravenous SUPPL-20 Bayer Hlthcare Labeling Approved Doxercalciferol ANDA #203875 Doxercalciferol Injectable; Injection SUPPL-4 Sun Pharm Manufacturing (CMC) Approved Adapalene and Benzoyl Peroxide ANDA #209641 Adapalene; Benzoyl Peroxide Gel; Topical ORIG-1 Actavis Labs Ut Inc   Tentative Approval Bijuva NDA #210132 Estradiol; Progesterone Capsule; Oral SUPPL-6 Therapeuticsmd Inc Efficacy Approved Albuterol Sulfate ANDA #214531 Albuterol Sulfate Solution; Inhalation ORIG-1 Ritedose Corp   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