CDER New: 12/01/2020

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 November 30, 2020 Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program (new) Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry FDA Drug Shortages Dexmedetomidine Injection (Updated - Currently in Shortage) Pindolol Tablets (New - 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. November 30, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Amitiza NDA #021908 Lubiprostone Capsule; Oral SUPPL-18 Sucampo Pharma Llc Labeling Approved November 27, 2020 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Prevacid NDA #020406 Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved Prevacid NDA #020406 Lansoprazole Capsule, Delayed Rel Pellets; Oral SUPPL-92 Takeda Pharms Usa Labeling Approved Aciphex NDA #020973 Rabeprazole Sodium Tablet, Delayed Release; Oral SUPPL-41 Eisai Inc Labeling Approved Protonix NDA #020987 Pantoprazole Sodium Tablet, Delayed Release; Oral SUPPL-56 Wyeth Pharms Labeling Approved Protonix Iv NDA #020988 Pantoprazole Sodium Injectable; Iv (Infusion) SUPPL-62 Wyeth Pharms Labeling Approved Nexium NDA #021153 Esomeprazole Magnesium Capsule, Delayed Rel Pellets; Oral SUPPL-57 Astrazeneca Pharms Labeling Approved Prevacid NDA #021428 Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved Prevacid NDA #021428 Lansoprazole Tablet, Orally Disintegrating, Delayed Release; Oral SUPPL-39 Takeda Pharms Usa Labeling Approved Finacea NDA #021470 Azelaic Acid Gel; Topical SUPPL-15 Leo Pharma As Labeling Approved Finacea NDA #021470 Azelaic Acid Gel; Topical SUPPL-16 Leo Pharma As Labeling Approved Zegerid NDA #021636 Omeprazole; Sodium Bicarbonate For Suspension; Oral SUPPL-22 Salix Labeling Approved Nexium Iv NDA #021689 Esomeprazole Sodium Injectable; Intravenous SUPPL-35 Astrazeneca Pharms Labeling Approved Zegerid NDA #021849 Omeprazole; Sodium Bicarbonate Capsule; Oral SUPPL-16 Salix Labeling Approved Nexium NDA #021957 Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-24 Astrazeneca Pharms Labeling Approved Protonix NDA #022020 Pantoprazole Sodium For Suspension, Delayed Release; Oral SUPPL-18 Wyeth Pharms Labeling Approved Prilosec NDA #022056 Omeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-23 Covis Pharma Bv Labeling Approved Nexium NDA #022101 Esomeprazole Magnesium For Suspension, Delayed Release; Oral SUPPL-21 Astrazeneca Pharms Labeling Approved Dexilant NDA #022287 Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved Dexilant NDA #022287 Dexlansoprazole Capsule, Delayed Release; Oral SUPPL-34 Takeda Pharms Usa Labeling Approved Vimovo NDA #022511 Esomeprazole Magnesium; Naproxen Tablet, Delayed Release; Oral SUPPL-25 Horizon Labeling Approved Omeprazole and Clarithromycin and Amoxicillin NDA #050824 Amoxicillin; Clarithromycin; Omeprazole Capsule, Tablet, Capsule, Delayed Release; Oral SUPPL-9 Cumberland Pharms Labeling Approved Fluconazole In Sodium Chloride 0.9% ANDA #076087 Fluconazole Injectable; Injection SUPPL-16 West-Ward Pharms Int Labeling Approved Teflaro NDA #200327 Ceftaroline Fosamil Powder; Intravenous SUPPL-25 Allergan Labeling Approved Esomeprazole Strontium NDA #202342 Esomeprazole Strontium Capsule, Delayed Release; Oral SUPPL-6 Belcher Labeling Approved Aciphex Sprinkle NDA #204736 Rabeprazole Sodium Capsule, Delayed Release; Oral SUPPL-12 Aytu Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved Yosprala NDA #205103 Aspirin; Omeprazole Tablet, Delayed Release; Oral SUPPL-6 Genus Lifesciences Labeling Approved Levetiracetam ANDA #205130 Levetiracetam Tablet, Extended Release; Oral ORIG-1 Sciegen Pharms Inc   Approved Brinzolamide ANDA #209406 Brinzolamide Suspension/Drops; Ophthalmic ORIG-1 Watson Labs Inc   Approved Pantoprazole Sodium NDA #209463 Pantoprazole Sodium Powder; Iv (Infusion) SUPPL-11 Hikma Labeling Approved Methenamine Hippurate ANDA #210068 Methenamine Hippurate Tablet; Oral ORIG-1 Riconpharma Llc   Approved Talicia NDA #213004 Amoxicillin; Omeprazole Magnesium; Rifabutin Capsule, Delayed Release; Oral SUPPL-2 Redhill Labeling Approved Nitazoxanide ANDA #213820 Nitazoxanide Tablet; Oral ORIG-1 Rising   Approved Chlorthalidone ANDA #214129 Chlorthalidone Tablet; Oral ORIG-1 Ajanta Pharma 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