CDER New: 7/7/2022

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 July 5, 2022 Drugs@FDA Data Files (updated) Guidance for Industry: Identifying Trading Partners Under the Drug Supply Chain Security Act 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. July 5, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Miralax NDA #022015 Polyethylene Glycol 3350 For Solution; Oral SUPPL-43 Bayer Healthcare Llc Labeling Approved Dextroamp Saccharate, Amp Aspartate, Dextroamp Sulfate and Amp Sulfate ANDA #210754 Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablet; Oral ORIG-1 Cediprof Inc   Approved Triamcinolone Acetonide ANDA #212400 Triamcinolone Acetonide Injectable; Injection ORIG-1 Eugia Pharma   Approved Glycopyrrolate ANDA #212467 Glycopyrrolate Solution; Oral ORIG-1 Suven Pharms   Approved Glycopyrrolate ANDA #213698 Glycopyrrolate Solution; Oral ORIG-1 Annora Pharma   Approved July 1, 2022 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Levemir BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Flexpen BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Flexpen BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Flexpen BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Flextouch BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Flextouch BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Flextouch BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Innolet BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Innolet BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Innolet BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Penfill BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Penfill BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Levemir Penfill BLA #021536 Insulin Detemir Recombinant Injectable; Subcutaneous SUPPL-60 Novo Nordisk Inc Labeling Approved Losartan Potassium ANDA #090083 Losartan Potassium Tablet; Oral SUPPL-31 Aurobindo Pharma Labeling Approved Losartan Potassium ANDA #200290 Losartan Potassium Tablet; Oral SUPPL-6 Ipca Labs Ltd Labeling Approved Haloperidol ANDA #200854 Haloperidol Tablet; Oral ORIG-1 Actavis Group   Approved Tresiba BLA #203314 Insulin Degludec Solution; Subcutaneous SUPPL-20 Novo Efficacy Approved Tresiba BLA #203314 Insulin Degludec Solution; Subcutaneous SUPPL-18 Novo Labeling Approved Tresiba BLA #203314 Insulin Degludec Solution; Subcutaneous SUPPL-18 Novo Labeling Approved Tresiba BLA #203314 Insulin Degludec Solution; Subcutaneous SUPPL-18 Novo Labeling Approved Azelaic Acid ANDA #204637 Azelaic Acid Gel; Topical SUPPL-3 Glenmark Pharms Labeling Approved Azelaic Acid ANDA #204637 Azelaic Acid Gel; Topical SUPPL-5 Glenmark Pharms Labeling Approved Glipizide ANDA #204720 Glipizide Tablet, Extended Release; Oral SUPPL-11 Unique Pharm Labs Manufacturing (CMC) Approved Glipizide ANDA #204720 Glipizide Tablet, Extended Release; Oral SUPPL-11 Unique Pharm Labs Manufacturing (CMC) Approved Olmesartan Medoxomil ANDA #204814 Olmesartan Medoxomil Tablet; Oral SUPPL-13 Macleods Pharms Ltd Labeling Approved Olmesartan Medoxomil ANDA #205192 Olmesartan Medoxomil Tablet; Oral SUPPL-1 Zydus Pharms Labeling Approved Olmesartan Medoxomil ANDA #206372 Olmesartan Medoxomil Tablet; Oral SUPPL-1 Micro Labs Labeling Approved Azelaic Acid ANDA #208724 Azelaic Acid Gel; Topical SUPPL-5 Tolmar Labeling Approved Perampanel ANDA #209801 Perampanel Tablet; Oral ORIG-1 Teva Pharms Usa Inc   Tentative Approval Dasatinib ANDA #211094 Dasatinib Tablet; Oral ORIG-1 Teva Pharms Usa Inc   Tentative Approval Ranolazine ANDA #212889 Ranolazine Tablet, Extended Release; Oral SUPPL-2 Graviti Pharms Manufacturing (CMC) Approved Acyclovir ANDA #215669 Acyclovir Suspension; Oral ORIG-1 Hetero Labs Ltd Iii   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