CDER New: 3/31/2021

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 March 30, 2021 FDA Drug Shortages Chlordiazepoxide Hydrochloride USP, Capsules (New - Currently in Shortage) Midazolam Injection, USP (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. March 30, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Cipro NDA #019537 Ciprofloxacin Hydrochloride Tablet; Oral SUPPL-93 Bayer Hlthcare Labeling Approved Cipro NDA #020780 Ciprofloxacin For Suspension; Oral SUPPL-49 Bayer Hlthcare Labeling Approved Cipro Xr NDA #021473 Ciprofloxacin; Ciprofloxacin Hydrochloride Tablet, Extended Release; Oral SUPPL-43 Bayer Hlthcare Labeling Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-106 Merck Sharp Dohme Labeling Approved Keytruda BLA #125514 Pembrolizumab Powder, For Injection Solution, Lyophilized Powder SUPPL-106 Merck Sharp Dohme Labeling Approved Opdivo BLA #125554 Nivolumab Injectable; Injection SUPPL-98 Bristol Myers Squibb Labeling Approved Vyxeos NDA #209401 Cytarabine; Daunorubicin Powder; Intravenous SUPPL-6 Celator Pharms Efficacy Approved March 29, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Methotrexate Lpf NDA #011719 Methotrexate Sodium Injectable; Injection SUPPL-131 Hospira Efficacy Approved Methotrexate Preservative Free NDA #011719 Methotrexate Sodium Injectable; Injection SUPPL-131 Hospira Efficacy Approved Methotrexate Sodium NDA #011719 Methotrexate Sodium Injectable; Injection SUPPL-131 Hospira Efficacy Approved Methotrexate Sodium Preservative Free NDA #011719 Methotrexate Sodium Injectable; Injection SUPPL-131 Hospira Efficacy Approved Ditropan Xl NDA #020897 Oxybutynin Chloride Tablet, Extended Release; Oral SUPPL-38 Janssen Pharms Labeling Approved Naproxen Sodium ANDA #074289 Naproxen Sodium Tablet; Oral SUPPL-6 Teva Pharms Labeling Approved Naproxen Sodium ANDA #074289 Naproxen Sodium Tablet; Oral SUPPL-6 Teva Pharms Labeling Approved Diclofenac Sodium ANDA #075281 Diclofenac Sodium Tablet, Delayed Release; Oral SUPPL-9 Mylan Pharms Inc Labeling Approved Diclofenac Sodium ANDA #075910 Diclofenac Sodium Tablet, Extended Release; Oral SUPPL-25 Actavis Elizabeth Labeling Approved Teriflunomide ANDA #209702 Teriflunomide Tablet; Oral SUPPL-2 Mylan Labeling Approved Teriflunomide ANDA #209702 Teriflunomide Tablet; Oral SUPPL-2 Mylan Labeling Approved Efinaconazole ANDA #212066 Efinaconazole Solution; Topical ORIG-1 Aurobindo Pharma Ltd   Approved Deferiprone ANDA #213239 Deferiprone Tablet; Oral ORIG-1 Hikma   Approved Leflunomide ANDA #213652 Leflunomide Tablet; Oral ORIG-1 Aurobindo Pharma Ltd   Approved Succinylcholine Chloride ANDA #215022 Succinylcholine Chloride Injectable; Injection ORIG-1 Sagent Pharms Inc   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