CDER New: 1/31/2022

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 28, 2022 Activities Report of the Generic Drugs Program (FY 2021) – FDARA Title VIII Section 807 and 805 (Updated) FDA Drug Shortages Sodium Bicarbonate Injection (Updated - Currently in Shortage) Vitamin A Palmitate (Aquasol A) 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. January 28, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Vfend NDA #021266 Voriconazole Tablet; Oral SUPPL-52 Pf Prism Cv Labeling Approved Vfend NDA #021267 Voriconazole Injectable; Intravenous SUPPL-62 Pf Prism Cv Labeling Approved Vfend NDA #021630 Voriconazole For Suspension; Oral SUPPL-41 Pf Prism Cv Labeling Approved January 27, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Camptosar NDA #020571 Irinotecan Hydrochloride Injectable; Injection SUPPL-52 Pfizer Inc Labeling Approved Camptosar NDA #020571 Irinotecan Hydrochloride Injectable; Injection SUPPL-53 Pfizer Inc Labeling Approved Seroquel NDA #020639 Quetiapine Fumarate Tablet; Oral SUPPL-72 Astrazeneca Labeling Approved Seroquel Xr NDA #022047 Quetiapine Fumarate Tablet, Extended Release; Oral SUPPL-46 Astrazeneca Labeling Approved Adasuve NDA #022549 Loxapine Powder; Inhalation SUPPL-10 Alexza Pharms Labeling Approved Adasuve NDA #022549 Loxapine Powder; Inhalation SUPPL-10 Alexza Pharms Labeling Approved Idarubicin Hydrochloride Pfs ANDA #065036 Idarubicin Hydrochloride Injectable; Injection SUPPL-33 Teva Pharms Usa Labeling Approved Tri-Sprintec ANDA #075808 Ethinyl Estradiol; Norgestimate Tablet; Oral-28 SUPPL-34 Barr Labeling Approved Tri-Sprintec ANDA #075808 Ethinyl Estradiol; Norgestimate Tablet; Oral-28 SUPPL-34 Barr Labeling Approved Nebivolol Hydrochloride ANDA #203659 Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Ani Pharms Labeling Approved Nebivolol Hydrochloride ANDA #203659 Nebivolol Hydrochloride Tablet; Oral SUPPL-3 Ani Pharms Labeling Approved Temozolomide ANDA #203898 Temozolomide Capsule; Oral SUPPL-4 Lannett Co Inc Labeling Approved Temozolomide ANDA #203898 Temozolomide Capsule; Oral SUPPL-5 Lannett Co Inc Labeling Approved Temozolomide ANDA #203898 Temozolomide Capsule; Oral SUPPL-4 Lannett Co Inc Labeling Approved Pennsaid NDA #204623 Diclofenac Sodium Solution; Topical SUPPL-9 Horizon Labeling Approved Proair Digihaler NDA #205636 Albuterol Sulfate Powder, Metered; Inhalation SUPPL-23 Teva Branded Pharm Labeling Approved Proair Respiclick NDA #205636 Albuterol Sulfate Powder, Metered; Inhalation SUPPL-23 Teva Branded Pharm Labeling Approved Memantine Hydrochloride ANDA #205784 Memantine Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Anchen Pharms Labeling Approved Memantine Hydrochloride ANDA #205784 Memantine Hydrochloride Capsule, Extended Release; Oral SUPPL-8 Anchen Pharms Labeling Approved Temozolomide ANDA #206309 Temozolomide Capsule; Oral SUPPL-1 Rising Labeling Approved Temozolomide ANDA #206309 Temozolomide Capsule; Oral SUPPL-2 Rising Labeling Approved Temozolomide ANDA #206309 Temozolomide Capsule; Oral SUPPL-1 Rising Labeling Approved Armonair Digihaler NDA #208798 Fluticasone Propionate Powder; Inhalation SUPPL-10 Teva Pharm Labeling Approved Armonair Respiclick NDA #208798 Fluticasone Propionate Powder; Inhalation SUPPL-10 Teva Pharm Labeling Approved Airduo Digihaler NDA #208799 Fluticasone Propionate; Salmeterol Xinafoate Powder; Inhalation SUPPL-19 Teva Pharm Labeling Approved Airduo Respiclick NDA #208799 Fluticasone Propionate; Salmeterol Xinafoate Powder; Inhalation SUPPL-19 Teva Pharm Labeling Approved Ertapenem Sodium ANDA #209133 Ertapenem Sodium Injectable; Intramuscular, Intravenous SUPPL-5 Eugia Pharma Labeling Approved Pifeltro NDA #210806 Doravirine Tablet; Oral SUPPL-7 Msd Merck Co Efficacy Approved Delstrigo NDA #210807 Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate Tablet; Oral SUPPL-8 Msd Merck Co Efficacy Approved Sofosbuvir ANDA #211353 Sofosbuvir Tablet; Oral ORIG-1 Teva Pharms Usa Inc   Approved Furosemide ANDA #212803 Furosemide Injectable; Injection ORIG-1 Hong Kong   Approved Lampit NDA #213464 Nifurtimox Tablet; Oral SUPPL-3 Bayer Healthcare Labeling Approved Potassium Chloride ANDA #213467 Potassium Chloride For Solution; Oral ORIG-1 Granules   Approved Carboprost Tromethamine ANDA #215337 Carboprost Tromethamine Injectable; Injection ORIG-1 Amneal   Approved Metronidazole ANDA #215794 Metronidazole Gel; Vaginal ORIG-1 Glenmark Pharms Ltd   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