CDER New: 10/13/2021

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 October 12, 2021 FDA Drug Shortages Atropine Sulfate Injection (Updated - Currently in Shortage) Bumetanide Injection (Updated - Currently in Shortage) Ceftolozane and Tazobactam (Zerbaxa) Injection (Updated - Currently in Shortage) Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage) Diltiazem Hydrochloride Injection (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (New - Currently in Shortage) Echothiophate Iodide (Phospholine Iodide) Ophthalmic Solution (Updated - Currently in Shortage) Enalaprilat Injection (Updated - Currently in Shortage) Famotidine Injection (Updated - Currently in Shortage) Fentanyl Citrate (Sublimaze) Injection (Updated - Currently in Shortage) Floxuridine for Injection (Updated - Currently in Shortage) Ketamine Injection (Updated - Currently in Shortage) Leucovorin Calcium Lyophilized Powder for Injection (Updated - Currently in Shortage) Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage) Morphine Sulfate Injection (Updated - Currently in Shortage) Montelukast Sodium Chewable Tablet (New - Discontinuation) Propofol Injectable Emulsion (Updated - Currently in Shortage) Valproate Sodium Injection (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. October 12, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Eliquis NDA #202155 Apixaban Tablet; Oral SUPPL-34 Bristol Myers Squibb Labeling Approved Eliquis NDA #202155 Apixaban Tablet; Oral SUPPL-34 Bristol Myers Squibb Labeling Approved Minivelle NDA #203752 Estradiol Film, Extended Release; Transdermal SUPPL-16 Noven Labeling Approved Verzenio NDA #208716 Abemaciclib Tablet; Oral SUPPL-6 Eli Lilly and Co Efficacy Approved Verzenio NDA #208716 Abemaciclib Tablet; Oral SUPPL-7 Eli Lilly and Co Efficacy Approved Verzenio NDA #208716 Abemaciclib Tablet; Oral SUPPL-8 Eli Lilly and Co Efficacy Approved October 8, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Absorica NDA #021951 Isotretinoin Capsule; Oral SUPPL-18 Sun Pharm Inds Inc REMS Approved Cefazolin and Dextrose NDA #050779 Cefazolin Sodium Injectable; Injection SUPPL-31 B Braun Labeling Approved Cefuroxime Sodium ANDA #064124 Cefuroxime Sodium Injectable; Injection SUPPL-18 Acs Dobfar Spa Labeling Approved Cefuroxime Sodium ANDA #064125 Cefuroxime Sodium Injectable; Injection SUPPL-13 Acs Dobfar Spa Labeling Approved Cefuroxime Sodium ANDA #064125 Cefuroxime Sodium Injectable; Intramuscular, Intravenous SUPPL-13 Acs Dobfar Spa Labeling Approved Fluoxetine ANDA #075662 Fluoxetine Hydrochloride Capsule; Oral SUPPL-2 Watson Labs Labeling Approved Fluoxetine ANDA #075662 Fluoxetine Hydrochloride Capsule; Oral SUPPL-2 Watson Labs Labeling Approved Amnesteem ANDA #075945 Isotretinoin Capsule; Oral SUPPL-40 Mylan Pharms Inc REMS Approved Claravis ANDA #076135 Isotretinoin Capsule; Oral SUPPL-52 Teva Pharms Usa REMS Approved Fluoxetine Hydrochloride ANDA #076237 Fluoxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-6 Barr Labeling Approved Fluoxetine Hydrochloride ANDA #076237 Fluoxetine Hydrochloride Capsule, Delayed Rel Pellets; Oral SUPPL-6 Barr Labeling Approved Claravis ANDA #076356 Isotretinoin Capsule; Oral SUPPL-47 Teva Pharms Usa REMS Approved Myorisan ANDA #076485 Isotretinoin Capsule; Oral SUPPL-27 Douglas Pharms REMS Approved Zenatane ANDA #202099 Isotretinoin Capsule; Oral SUPPL-24 Dr Reddys Labs Ltd REMS Approved Isotretinoin ANDA #205063 Isotretinoin Capsule; Oral SUPPL-1 Actavis Labs Fl REMS Approved Isotretinoin ANDA #207792 Isotretinoin Capsule; Oral SUPPL-14 Amneal Pharms Ny REMS Approved Alvimopan ANDA #208295 Alvimopan Capsule; Oral SUPPL-2 Watson Labs Teva Labeling Approved Clobazam ANDA #209718 Clobazam Tablet; Oral SUPPL-3 Amneal Pharms Co Labeling Approved Clobazam ANDA #209718 Clobazam Tablet; Oral SUPPL-3 Amneal Pharms Co Labeling Approved Clobazam ANDA #209795 Clobazam Tablet; Oral SUPPL-2 Hetero Labs Ltd Iii Labeling Approved Absorica Ld NDA #211913 Isotretinoin Capsule; Oral SUPPL-4 Sun Pharm REMS Approved Isotretinoin ANDA #212333 Isotretinoin Capsule; Oral SUPPL-1 Upsher Smith Labs REMS Approved Sildenafil Citrate ANDA #212883 Sildenafil Citrate For Suspension; Oral SUPPL-3 Ajanta Pharma Ltd Labeling Approved Isotretinoin ANDA #213571 Isotretinoin Capsule; Oral SUPPL-1 Upsher Smith Labs REMS Approved Penicillamine ANDA #214363 Penicillamine Capsule; Oral ORIG-1 Navinta Llc   Approved Diclofenac Potassium ANDA #215585 Diclofenac Potassium Tablet; Oral ORIG-1 Riconpharma Llc   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