CDER New: 1/21/2021

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 January 19, 2021 Drugs@FDA Data Files (updated) Public Notifications: Adam's Secret Extra Strength 1500 contains hidden drug ingredients Adam's Secret Extra Strength 3000 Platinum contains hidden drug ingredients FDA Drug Shortages Ketoprofen Capsules (Updated - Currently in Shortage) Midazolam Injection, USP (Updated - Currently in Shortage) Orange Book Annual Edition (updated) Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19) 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 19, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Bloxiverz NDA #204078 Neostigmine Methylsulfate Solution; Intravenous SUPPL-10 Exela Pharma Labeling Approved Spritam NDA #207958 Levetiracetam Tablet, For Suspension; Oral SUPPL-19 Aprecia Pharms Efficacy Approved Verquvo NDA #214377 Vericiguat Tablet; Oral ORIG-1 Merck Sharp Dohme Type 1 - New Molecular Entity Approved January 15, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Azulfidine NDA #007073 Sulfasalazine Tablet; Oral SUPPL-129 Pharmacia and Upjohn Labeling Approved Azulfidine En-Tabs NDA #007073 Sulfasalazine Tablet, Delayed Release; Oral SUPPL-129 Pharmacia and Upjohn Labeling Approved Cellcept NDA #050722 Mycophenolate Mofetil Capsule; Oral SUPPL-44 Roche Palo REMS Approved Cellcept NDA #050723 Mycophenolate Mofetil Tablet; Oral SUPPL-44 Roche Palo REMS Approved Cellcept NDA #050758 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-41 Roche Palo REMS Approved Cellcept NDA #050759 Mycophenolate Mofetil Suspension; Oral SUPPL-49 Roche Palo REMS Approved Myfortic NDA #050791 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-33 Novartis REMS Approved Mycophenolate Mofetil ANDA #065379 Mycophenolate Mofetil Capsule; Oral SUPPL-27 Sandoz REMS Approved Mycophenolate Mofetil ANDA #065410 Mycophenolate Mofetil Capsule; Oral SUPPL-14 Hikma REMS Approved Mycophenolate Mofetil ANDA #065413 Mycophenolate Mofetil Tablet; Oral SUPPL-15 Hikma REMS Approved Mycophenolate Mofetil ANDA #065416 Mycophenolate Mofetil Tablet; Oral SUPPL-18 Accord Hlthcare REMS Approved Mycophenolate Mofetil ANDA #065451 Mycophenolate Mofetil Tablet; Oral SUPPL-27 Sandoz REMS Approved Mycophenolate Mofetil ANDA #065457 Mycophenolate Mofetil Tablet; Oral SUPPL-13 Teva Pharms REMS Approved Mycophenolate Mofetil ANDA #065491 Mycophenolate Mofetil Capsule; Oral SUPPL-21 Teva Pharms REMS Approved Mycophenolate Mofetil ANDA #065520 Mycophenolate Mofetil Capsule; Oral SUPPL-26 Mylan REMS Approved Mycophenolate Mofetil ANDA #065521 Mycophenolate Mofetil Tablet; Oral SUPPL-24 Mylan REMS Approved Mycophenolate Mofetil ANDA #090055 Mycophenolate Mofetil Capsule; Oral SUPPL-17 Strides Pharma REMS Approved Mycophenolate Mofetil ANDA #090111 Mycophenolate Mofetil Capsule; Oral SUPPL-10 Vintage Pharms Llc REMS Approved Mycophenolate Mofetil ANDA #090253 Mycophenolate Mofetil Capsule; Oral SUPPL-18 Accord Hlthcare REMS Approved Mycophenolate Mofetil ANDA #090456 Mycophenolate Mofetil Tablet; Oral SUPPL-19 Strides Pharma REMS Approved Mycophenolate Mofetil ANDA #090606 Mycophenolate Mofetil Tablet; Oral SUPPL-9 Amneal REMS Approved Mycophenolate Mofetil ANDA #090661 Mycophenolate Mofetil Tablet; Oral SUPPL-6 Jubilant Cadista REMS Approved Mycophenolate Mofetil ANDA #090762 Mycophenolate Mofetil Capsule; Oral SUPPL-6 Jubilant Cadista REMS Approved Mycophenolic Acid ANDA #091248 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-14 Rk Pharma REMS Approved Mycophenolate Mofetil ANDA #091249 Mycophenolate Mofetil Tablet; Oral SUPPL-20 Alkem Labs Ltd REMS Approved Mycophenolic Acid ANDA #091558 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-12 Apotex Inc REMS Approved Mycophenolate Mofetil ANDA #200197 Mycophenolate Mofetil Capsule; Oral SUPPL-17 Alkem Labs Ltd REMS Approved Mycophenolic Acid ANDA #202555 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-2 Accord Hlthcare REMS Approved Mycophenolic Acid ANDA #202720 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-7 Teva Pharms Usa REMS Approved Mycophenolate Mofetil ANDA #203005 Mycophenolate Mofetil Suspension; Oral SUPPL-13 Alkem Labs Ltd REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #203575 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-4 Par Sterile Products REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #203859 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-3 Mylan Labs Ltd REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #204043 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-8 Akorn Inc REMS Approved Mycophenolate Mofetil ANDA #204076 Mycophenolate Mofetil Tablet; Oral SUPPL-2 Zhejiang Hisun Pharm REMS Approved Mycophenolate Mofetil ANDA #204077 Mycophenolate Mofetil Capsule; Oral SUPPL-2 Zhejiang Hisun Pharm REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #204473 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-4 Zydus Pharms REMS Approved Ezetimibe and Atorvastatin Calcium ANDA #206084 Atorvastatin Calcium; Ezetimibe Tablet; Oral SUPPL-3 Scov3 Labeling Approved Ferumoxytol ANDA #206604 Ferumoxytol Solution; Intravenous ORIG-1 Sandoz Inc   Approved Acetaminophen NDA #206610 Acetaminophen Injectable; Injection ORIG-1 Mylan Labs Ltd Type 5 - New Formulation or New Manufacturer Approved Mycophenolate Mofetil ANDA #210181 Mycophenolate Mofetil Capsule; Oral SUPPL-6 Concord Biotech Ltd REMS Approved Mycophenolate Mofetil ANDA #210370 Mycophenolate Mofetil Suspension; Oral SUPPL-5 Vistapharm REMS Approved Epoprostenol Sodium ANDA #210473 Epoprostenol Sodium Injectable; Injection ORIG-1 Sun Pharm   Approved Baclofen ANDA #210777 Baclofen Injectable; Intrathecal ORIG-1 Maia Pharms Inc   Approved Mycophenolic Acid ANDA #211173 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-4 Concord Biotech Ltd REMS Approved Methylergonovine Maleate ANDA #211919 Methylergonovine Maleate Tablet; Oral ORIG-1 Rising   Approved Mycophenolate Mofetil ANDA #212087 Mycophenolate Mofetil Tablet; Oral SUPPL-2 Concord Biotech Ltd REMS Approved Regadenoson ANDA #213210 Regadenoson Unknown ORIG-1 Dr Reddys Labs Ltd   Tentative Approval Norepinephrine Bitartrate;Dextrose NDA #214313 Norepinephrine Bitartrate;Dextrose Injectable; Injection ORIG-1 Baxter Hlthcare Corp Type 5 - New Formulation or New Manufacturer Approved Enhertu BLA #761139 Fam-Trastuzumab Deruxtecan-Nxki Injectable; Injection SUPPL-11 Daiichi Sankyo Efficacy Approved Darzalex Faspro BLA #761145 Daratumumab;Hyaluronidase-Fihj Injectable; Injection SUPPL-2 Janssen Biotech Efficacy 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