CDER New: 1/4/2021

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 31, 2020 FDA Drug Shortages New (12/30/2020) Famotidine Injection (Currently in Shortage) Valproate Sodium Injection, USP (Currently in Shortage) New (12/28/2020) Diphenhydramine Hydrochloride Injection, USP (Discontinuation) Hydrocodone/Homatropine Tablets (Discontinuation) Misoprostol (Cytotec) Tablets (Currently in Shortage) Misoprostol Tablets (Currently in Shortage) Updated (12/30/2020) Azithromycin Tablets (Resolved) Bupivacaine Hydrochloride and Epinephrine Injection, USP (Currently in Shortage) Cefazolin Injection (Currently in Shortage) Cefotetan Disodium Injection (Currently in Shortage) Cisatracurium Besylate Injection (Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Currently in Shortage) Dexmedetomidine Injection (Currently in Shortage) Dextrose 50% Injection (Currently in Shortage) Dobutamine Hydrochloride Injection (Currently in Shortage) Dopamine Hydrochloride Injection (Currently in Shortage) Doxycycline Hyclate Injection (Currently in Shortage) Epinephrine Injection, 0.1 mg/mL (Currently in Shortage) Famotidine Injection (Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage) Heparin Sodium and Sodium Chloride 0.9% Injection (Currently in Shortage) Hydralazine Hydrochloride Injection, USP (Currently in Shortage) Hydrocortisone Tablets, USP (Currently in Shortage) Hydromorphone Hydrochloride Injection, USP (Currently in Shortage) Ketorolac Tromethamine Injection (Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection with Epinephrine (Currently in Shortage) Lorazepam Injection, USP (Currently in Shortage) Morphine Sulfate Injection, USP (Currently in Shortage) Nalbuphine Hydrochloride Injection (Currently in Shortage) Oxytocin Injection, USP Synthetic (Currently in Shortage) Pantoprazole Sodium for Injection (Currently in Shortage) Procainamide Hydrochloride Injection, USP (Resolved) Propofol Injectable Emulsion (Currently in Shortage) Ropivacaine Hydrochloride Injection (Currently in Shortage) Sodium Bicarbonate Injection, USP (Currently in Shortage) Sodium Chloride 23.4% Injection (Currently in Shortage) Updated (12/29/2020) Atropine Sulfate Injection (Currently in Shortage) Bumetanide Injection, USP (Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Currently in Shortage) Enalaprilat Injection, USP (Currently in Shortage) Etomidate Injection (Currently in Shortage) Famotidine Injection (Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Currently in Shortage) Hydromorphone Hydrochloride Injection, USP (Currently in Shortage) Ketamine Injection (Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage) Midazolam Injection, USP (Currently in Shortage) Morphine Sulfate Injection, USP (Currently in Shortage) Ondansetron Hydrochloride Injection (Currently in Shortage) Pantoprazole Sodium for Injection (Currently in Shortage) Updated (12/28/2020) Bupivacaine Hydrochloride Injection, USP (Currently in Shortage) Chlorothiazide (Diuril) Oral Suspension (Resolved) Cisatracurium Besylate Injection (Currently in Shortage) Etomidate Injection (Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage) Pantoprazole Sodium for Injection (Currently in Shortage) Ropivacaine Hydrochloride Injection (Currently in Shortage) Vecuronium Bromide for Injection (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 31, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Aleve NDA #020204 Naproxen Sodium Tablet; Oral SUPPL-77 Bayer Labeling Approved Aleve NDA #020204 Naproxen Sodium Tablet; Oral SUPPL-78 Bayer Labeling Approved Aleve NDA #020204 Naproxen Sodium Tablet; Oral SUPPL-79 Bayer Labeling Approved Aleve NDA #020204 Naproxen Sodium Tablet; Oral SUPPL-80 Bayer Labeling Approved Gonal-F BLA #020378 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-45 Emd Serono Labeling Approved Gonal-F BLA #020378 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-67 Emd Serono Labeling Approved Gonal-F BLA #020378 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-75 Emd Serono Labeling Approved Gonal-F BLA #021765 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-13 Emd Serono Labeling Approved Gonal-F BLA #021765 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-14 Emd Serono Labeling Approved Gonal-F BLA #021765 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-44 Emd Serono Labeling Approved Gonal-F Rff BLA #021765 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-13 Emd Serono Labeling Approved Gonal-F Rff BLA #021765 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-14 Emd Serono Labeling Approved Gonal-F Rff BLA #021765 Follitropin Alfa/Beta Injectable; Subcutaneous SUPPL-44 Emd Serono Labeling Approved December 30, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Prograf NDA #050708 Tacrolimus Capsule; Oral SUPPL-52 Astellas Labeling Approved Prograf NDA #050709 Tacrolimus Injectable; Injection SUPPL-44 Astellas Labeling Approved Astagraf Xl NDA #204096 Tacrolimus Capsule, Extended Release; Oral SUPPL-9 Astellas Labeling Approved Levofloxacin In Dextrose 5% In Plastic Container ANDA #206908 Levofloxacin Injectable; Injection ORIG-1 Gland Pharma Ltd   Approved Fingolimod Hydrochloride ANDA #208004 Fingolimod Hydrochloride Capsule; Oral ORIG-1 Alkem Labs Ltd   Approved Prograf NDA #210115 Tacrolimus For Suspension; Oral SUPPL-4 Astellas Labeling 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