FDA Drug Shortages (New) - October 5, 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 4, 2021 FDA Drug Shortages Timolol Maleate Ophthalmic Gel Forming Solution (Updated - Resolved) 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 4, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Venclexta NDA #208573 Venetoclax Tablet; Oral SUPPL-24 Abbvie Inc Efficacy Approved Trikafta (Copackaged) NDA #212273 Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor Tablet; Oral SUPPL-8 Vertex Pharms Inc Labeling Approved October 1, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Risperidone ANDA #076288 Risperidone Tablet; Oral SUPPL-20 Mylan Labeling Approved Lithium Carbonate ANDA #090702 Lithium Carbonate Capsule; Oral SUPPL-7 Hetero Labs Ltd Iii Labeling Approved Lithium Carbonate ANDA #090702 Lithium Carbonate Capsule; Oral SUPPL-7 Hetero Labs Ltd Iii Labeling Approved Lithium Carbonate ANDA #090702 Lithium Carbonate Capsule; Oral SUPPL-10 Hetero Labs Ltd Iii Labeling Approved Ondansetron Hydrochloride ANDA #091483 Ondansetron Hydrochloride Solution; Oral SUPPL-7 Amneal Pharms Labeling Approved Ramipril ANDA #091604 Ramipril Capsule; Oral SUPPL-10 Aurobindo Pharma Ltd Labeling Approved Levetiracetam ANDA #201464 Levetiracetam Tablet, Extended Release; Oral SUPPL-3 Pharmadax Inc Labeling Approved Levetiracetam ANDA #201464 Levetiracetam Tablet, Extended Release; Oral SUPPL-3 Pharmadax Inc Labeling Approved Ezetimibe and Simvastatin ANDA #202968 Ezetimibe; Simvastatin Tablet; Oral SUPPL-5 Watson Labs Inc Labeling Approved Ezetimibe and Simvastatin ANDA #202968 Ezetimibe; Simvastatin Tablet; Oral SUPPL-5 Watson Labs Inc Labeling Approved Jentadueto Xr NDA #208026 Linagliptin; Metformin Hydrochloride Tablet, Extended Release; Oral SUPPL-20 Boehringer Ingelheim Labeling Approved Neostigmine Methylsulfate ANDA #210652 Neostigmine Methylsulfate Solution; Intravenous ORIG-1 Indoco   Approved Caspofungin Acetate ANDA #211263 Caspofungin Acetate Powder; Intravenous ORIG-1 Ubi   Approved Talicia NDA #213004 Amoxicillin; Omeprazole Magnesium; Rifabutin Capsule, Delayed Release; Oral SUPPL-4 Redhill Labeling Approved Mexiletine Hydrochloride ANDA #214089 Mexiletine Hydrochloride Capsule; Oral ORIG-1 Havix   Approved Gabapentin ANDA #214957 Gabapentin Tablet; Oral ORIG-1 Ascent Pharms Inc   Approved Oseltamivir Phosphate ANDA #215208 Oseltamivir Phosphate Capsule; Oral ORIG-1 Epic Pharma Llc   Approved Dupixent BLA #761055 Dupilumab Injectable; Injection SUPPL-35 Regeneron Pharmaceuticals Labeling Approved Sogroya BLA #761156 Somapacitan-Beco Solution; Subcutaneous SUPPL-1 Novo Nordisk Inc Labeling Approved Sogroya BLA #761156 Somapacitan-Beco Solution; Subcutaneous SUPPL-2 Novo Nordisk Inc Labeling Approved Sogroya BLA #761156 Somapacitan-Beco Solution; Subcutaneous SUPPL-2 Novo Nordisk Inc Labeling Approved Sogroya BLA #761156 Somapacitan-Beco Solution; Subcutaneous SUPPL-1 Novo Nordisk Inc 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