CDER New: 8/31/2022

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 August 30, 2022 Drugs@FDA Data Files (updated) FDA Drug Shortages Fenoldopam Mesylate (Corlopam) Injection (New - Discontinuation) Procainamide Hydrochloride Injection (New - Discontinuation) Remifentanil Injection (Updated - Currently in Shortage) Synercid Injection (New -Discontinuation) Vecuronium Bromide for 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. August 30, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Synthroid NDA #021402 Levothyroxine Sodium Tablet; Oral SUPPL-36 Abbvie Labeling Approved Elelyso BLA #022458 Taliglucerase Alfa Powder; Intravenous SUPPL-29 Pfizer Labeling Approved Clenpiq NDA #209589 Citric Acid; Magnesium Oxide; Sodium Picosulfate Solution; Oral SUPPL-14 Ferring Pharms Inc Labeling Approved August 29, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Lastacaft NDA #022134 Alcaftadine Solution/Drops; Ophthalmic SUPPL-9 Allergan Labeling Approved Simvastatin ANDA #077691 Simvastatin Tablet; Oral SUPPL-43 Aurobindo Pharma Labeling Approved Simvastatin ANDA #077691 Simvastatin Tablet; Oral SUPPL-44 Aurobindo Pharma Labeling Approved Simvastatin ANDA #077691 Simvastatin Tablet; Oral SUPPL-45 Aurobindo Pharma Labeling Approved Simvastatin ANDA #078103 Simvastatin Tablet; Oral SUPPL-46 Lupin Labeling Approved Simvastatin ANDA #078103 Simvastatin Tablet; Oral SUPPL-49 Lupin Labeling Approved Simvastatin ANDA #078103 Simvastatin Tablet; Oral SUPPL-50 Lupin Labeling Approved Losartan Potassium ANDA #078232 Losartan Potassium Tablet; Oral SUPPL-39 Lupin Ltd Labeling Approved Losartan Potassium ANDA #078232 Losartan Potassium Tablet; Oral SUPPL-39 Lupin Ltd Labeling Approved Losartan Potassium and Hydrochlorothiazide ANDA #201682 Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-8 Ipca Labs Ltd Labeling Approved Losartan Potassium and Hydrochlorothiazide ANDA #201682 Hydrochlorothiazide; Losartan Potassium Tablet; Oral SUPPL-9 Ipca Labs Ltd Labeling Approved Olmesartan Medoxomil ANDA #202375 Olmesartan Medoxomil Tablet; Oral SUPPL-7 Torrent Labeling Approved Olmesartan Medoxomil ANDA #203281 Olmesartan Medoxomil Tablet; Oral SUPPL-2 Glenmark Pharms Ltd Labeling Approved Vigabatrin ANDA #213104 Vigabatrin Tablet; Oral ORIG-1 Hikma   Approved Loperamide Hydrochloride and Simethicone ANDA #215981 Loperamide Hydrochloride; Simethicone Tablet; Oral ORIG-1 Granules   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