CDER New: 8/13/2021

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 August 12, 2021 Pre-Hatch-Waxman Abbreviated New Drug Applications (PANDA) in the Orange Book (new) 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 12, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Xyrem NDA #021196 Sodium Oxybate Solution; Oral SUPPL-36 Jazz Pharms REMS Approved Linezolid In Sodium Chloride 0.9% In Plastic Container NDA #206473 Linezolid Solution; Intravenous SUPPL-4 Hospira Inc Labeling Approved Xywav NDA #212690 Calcium Oxybate; Magnesium Oxybate; Potassium Oxybate; Sodium Oxybate Solution; Oral SUPPL-6 Jazz Efficacy Approved August 11, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Quelicin NDA #008845 Succinylcholine Chloride Injectable; Injection SUPPL-76 Hospira Labeling Approved Quelicin Preservative Free NDA #008845 Succinylcholine Chloride Injectable; Injection SUPPL-76 Hospira Labeling Approved Mirena NDA #021225 Levonorgestrel Intrauterine Device; Intrauterine SUPPL-42 Bayer Hlthcare Efficacy Approved Moxeza NDA #022428 Moxifloxacin Hydrochloride Solution/Drops; Ophthalmic SUPPL-10 Novartis Labeling Approved Maxipime NDA #050679 Cefepime Hydrochloride Injectable; Injection SUPPL-46 Hospira Inc Labeling Approved Cellcept NDA #050722 Mycophenolate Mofetil Capsule; Oral SUPPL-48 Roche Palo REMS Approved Cellcept NDA #050723 Mycophenolate Mofetil Tablet; Oral SUPPL-48 Roche Palo REMS Approved Cellcept NDA #050758 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-45 Roche Palo REMS Approved Cellcept NDA #050759 Mycophenolate Mofetil Suspension; Oral SUPPL-53 Roche Palo REMS Approved Myfortic NDA #050791 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-36 Novartis REMS Approved Mycophenolate Mofetil ANDA #065379 Mycophenolate Mofetil Capsule; Oral SUPPL-30 Sandoz REMS Approved Mycophenolate Mofetil ANDA #065410 Mycophenolate Mofetil Capsule; Oral SUPPL-19 Hikma REMS Approved Mycophenolate Mofetil ANDA #065413 Mycophenolate Mofetil Tablet; Oral SUPPL-20 Hikma REMS Approved Mycophenolate Mofetil ANDA #065416 Mycophenolate Mofetil Tablet; Oral SUPPL-21 Accord Hlthcare REMS Approved Mycophenolate Mofetil ANDA #065451 Mycophenolate Mofetil Tablet; Oral SUPPL-30 Sandoz REMS Approved Mycophenolate Mofetil ANDA #065457 Mycophenolate Mofetil Tablet; Oral SUPPL-17 Teva Pharms REMS Approved Mycophenolate Mofetil ANDA #065491 Mycophenolate Mofetil Capsule; Oral SUPPL-23 Teva Pharms REMS Approved Mycophenolate Mofetil ANDA #065520 Mycophenolate Mofetil Capsule; Oral SUPPL-30 Mylan REMS Approved Mycophenolate Mofetil ANDA #065521 Mycophenolate Mofetil Tablet; Oral SUPPL-28 Mylan REMS Approved Mycophenolate Mofetil ANDA #090055 Mycophenolate Mofetil Capsule; Oral SUPPL-21 Strides Pharma REMS Approved Mycophenolate Mofetil ANDA #090111 Mycophenolate Mofetil Capsule; Oral SUPPL-12 Vintage Pharms Llc REMS Approved Mycophenolate Mofetil ANDA #090253 Mycophenolate Mofetil Capsule; Oral SUPPL-21 Accord Hlthcare REMS Approved Mycophenolate Mofetil ANDA #090456 Mycophenolate Mofetil Tablet; Oral SUPPL-24 Strides Pharma REMS Approved Mycophenolate Mofetil ANDA #090606 Mycophenolate Mofetil Tablet; Oral SUPPL-11 Amneal REMS Approved Mycophenolate Mofetil ANDA #090661 Mycophenolate Mofetil Tablet; Oral SUPPL-10 Jubilant Cadista REMS Approved Mycophenolate Mofetil ANDA #090762 Mycophenolate Mofetil Capsule; Oral SUPPL-10 Jubilant Cadista REMS Approved Mycophenolic Acid ANDA #091248 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-17 Rk Pharma REMS Approved Mycophenolate Mofetil ANDA #091249 Mycophenolate Mofetil Tablet; Oral SUPPL-24 Alkem Labs Ltd REMS Approved Mycophenolic Acid ANDA #091558 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-18 Apotex Inc REMS Approved Mycophenolate Mofetil ANDA #200197 Mycophenolate Mofetil Capsule; Oral SUPPL-21 Alkem Labs Ltd REMS Approved Varenicline ANDA #201785 Varenicline Tablet; Oral ORIG-1 Par Pharm Inc   Approved Mycophenolic Acid ANDA #202555 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-6 Accord Hlthcare REMS Approved Mycophenolic Acid ANDA #202720 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-9 Teva Pharms Usa REMS Approved Mycophenolate Mofetil ANDA #203005 Mycophenolate Mofetil Suspension; Oral SUPPL-17 Alkem Labs Ltd REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #203575 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-7 Par Sterile Products REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #203859 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-9 Mylan Labs Ltd REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #204043 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-11 Akorn REMS Approved Mycophenolate Mofetil ANDA #204076 Mycophenolate Mofetil Tablet; Oral SUPPL-4 Zhejiang Hisun Pharm REMS Approved Mycophenolate Mofetil ANDA #204077 Mycophenolate Mofetil Capsule; Oral SUPPL-4 Zhejiang Hisun Pharm REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #204473 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-6 Zydus Pharms REMS Approved Aspirin and Dipyridamole ANDA #209929 Aspirin; Dipyridamole Capsule, Extended Release; Oral ORIG-1 Micro Labs   Approved Mycophenolate Mofetil ANDA #210181 Mycophenolate Mofetil Capsule; Oral SUPPL-9 Concord Biotech Ltd REMS Approved Mycophenolate Mofetil ANDA #210370 Mycophenolate Mofetil Suspension; Oral SUPPL-9 Vistapharm REMS Approved Mycophenolic Acid ANDA #211173 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-7 Concord Biotech Ltd REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #211374 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-2 Amneal REMS Approved Mycophenolate Mofetil ANDA #212087 Mycophenolate Mofetil Tablet; Oral SUPPL-4 Concord Biotech Ltd REMS Approved Mycophenolate Mofetil Hydrochloride ANDA #212130 Mycophenolate Mofetil Hydrochloride Injectable; Injection SUPPL-3 Meitheal REMS Approved Loperamide Hydrochloride ANDA #213070 Loperamide Hydrochloride Capsule; Oral ORIG-1 Strides Pharma   Approved Metformin Hydrochloride ANDA #213359 Metformin Hydrochloride Tablet, Extended Release; Oral ORIG-1 Unichem   Approved Paroxetine Hydrochloride ANDA #213612 Paroxetine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Sinotherapeutics Inc   Approved Mycophenolic Acid ANDA #214376 Mycophenolic Acid Tablet, Delayed Release; Oral SUPPL-3 Amta REMS Approved Mycophenolate Mofetil ANDA #214525 Mycophenolate Mofetil Suspension; Oral SUPPL-1 Lannett Co Inc REMS 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