CDER New: 3/3/2021

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 2, 2021 Drug Info Rounds Video - Medication Guides: Distribution Requirements for Health Care Professionals (March 2020) Phonetic and Orthographic Computer Analysis (POCA) Program (updated) Drugs@FDA Data Files (updated) FDA Drug Shortages Leucovorin Calcium Lyophilized Powder for Injection (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 2, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Zemplar NDA #020819 Paricalcitol Solution; Intravenous SUPPL-36 Abbvie Labeling Approved March 1, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Xanax NDA #018276 Alprazolam Tablet; Oral SUPPL-55 Upjohn Labeling Approved Plavix NDA #020839 Clopidogrel Bisulfate Tablet; Oral SUPPL-74 Sanofi Aventis Us Labeling Approved Xanax Xr NDA #021434 Alprazolam Tablet, Extended Release; Oral SUPPL-18 Upjohn Labeling Approved Fludeoxyglucose F18 ANDA #204463 Fludeoxyglucose F-18 Injectable; Intravenous SUPPL-1 Decatur Labeling Approved Fluoxetine Hydrochloride ANDA #204597 Fluoxetine Hydrochloride Capsule; Oral SUPPL-11 Sciegen Pharms Inc Labeling Approved Triumeq NDA #205551 Abacavir Sulfate; Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-25 Viiv Hlthcare Efficacy Approved Firdapse NDA #208078 Amifampridine Phosphate Tablet; Oral SUPPL-7 Catalyst Pharms Labeling Approved Ibrutinib ANDA #211350 Ibrutinib Unknown ORIG-1 Teva Pharms Usa Inc   Tentative Approval Levorphanol Tartrate ANDA #211484 Levorphanol Tartrate Tablet; Oral SUPPL-2 Virtus Pharms Labeling Approved Doxepin Hydrochloride ANDA #211618 Doxepin Hydrochloride Capsule; Oral ORIG-1 Leading Pharma Llc   Approved Dovato NDA #211994 Dolutegravir Sodium; Lamivudine Tablet; Oral SUPPL-10 Viiv Hlthcare Efficacy Approved Fluphenazine Hydrochloride ANDA #214674 Fluphenazine Hydrochloride Tablet; Oral ORIG-1 Novitium Pharma   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