CDER New: 8/31/2021

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 August 30, 2021 Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards La Administración de Alimentos y Medicamentos de EE. UU. (FDA, por sus siglas en inglés) solicita la retirada de la advertencia de más estricta sobre el uso de estatinas hipocolesterolemiantes durante el embarazo 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 27, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Fluoxetine Hydrochloride ANDA #075872 Fluoxetine Hydrochloride Tablet; Oral SUPPL-25 Teva Labeling Approved Fluoxetine Hydrochloride ANDA #075872 Fluoxetine Hydrochloride Tablet; Oral SUPPL-27 Teva Labeling Approved Fluoxetine Hydrochloride ANDA #075872 Fluoxetine Hydrochloride Tablet; Oral SUPPL-25 Teva Labeling Approved Fluoxetine Hydrochloride ANDA #075872 Fluoxetine Hydrochloride Tablet; Oral SUPPL-27 Teva Labeling Approved Fluoxetine Hydrochloride ANDA #076015 Fluoxetine Hydrochloride Solution; Oral SUPPL-16 Pharm Assoc Labeling Approved Fluoxetine Hydrochloride ANDA #076015 Fluoxetine Hydrochloride Solution; Oral SUPPL-16 Pharm Assoc Labeling Approved Fluoxetine Hydrochloride ANDA #076015 Fluoxetine Hydrochloride Solution; Oral SUPPL-20 Pharm Assoc Labeling Approved Mydriacyl ANDA #084305 Tropicamide Solution/Drops; Ophthalmic SUPPL-38 Sandoz Inc Labeling Approved Mydriacyl ANDA #084305 Tropicamide Solution/Drops; Ophthalmic SUPPL-38 Sandoz Inc Labeling Approved Lidocaine Hydrochloride Preservative Free ANDA #088295 Lidocaine Hydrochloride Injectable; Injection SUPPL-24 Hospira Labeling Approved Buprenorphine Hydrochloride ANDA #201066 Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-12 Mylan Labeling Approved Buprenorphine Hydrochloride ANDA #201066 Buprenorphine Hydrochloride Tablet; Sublingual SUPPL-12 Mylan Labeling Approved Briviact NDA #205836 Brivaracetam Tablet; Oral SUPPL-9 Ucb Inc Efficacy Approved Briviact NDA #205837 Brivaracetam Solution; Intravenous SUPPL-7 Ucb Inc Efficacy Approved Briviact NDA #205838 Brivaracetam Solution; Oral SUPPL-6 Ucb Inc Efficacy Approved Penicillamine ANDA #209921 Penicillamine Capsule; Oral SUPPL-6 Ani Pharms Labeling Approved Paroxetine Hydrochloride ANDA #212645 Paroxetine Hydrochloride Tablet, Extended Release; Oral ORIG-1 Cadila Pharms Ltd   Approved August 26, 2021 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Latisse NDA #022369 Bimatoprost Solution/Drops; Topical SUPPL-14 Allergan Labeling Approved Diazepam ANDA #072370 Diazepam Injectable; Injection SUPPL-8 Watson Labs Inc Labeling Approved Diazepam ANDA #072370 Diazepam Injectable; Injection SUPPL-9 Watson Labs Inc Labeling Approved Fluoxetine ANDA #075662 Fluoxetine Hydrochloride Capsule; Oral SUPPL-1 Watson Labs Labeling Approved Fluoxetine ANDA #075662 Fluoxetine Hydrochloride Capsule; Oral SUPPL-1 Watson Labs Labeling Approved Olanzapine ANDA #078109 Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-5 Par Pharm Labeling Approved Olanzapine ANDA #078109 Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-7 Par Pharm Labeling Approved Olanzapine ANDA #078109 Olanzapine Tablet, Orally Disintegrating; Oral SUPPL-8 Par Pharm Labeling Approved Olopatadine Hydrochloride ANDA #200810 Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-1 Wockhardt Ltd Labeling Approved Oxycodone and Acetaminophen ANDA #201448 Acetaminophen; Oxycodone Hydrochloride Solution; Oral ORIG-1 Nostrum Labs Inc   Approved Irbesartan ANDA #203020 Irbesartan Tablet; Oral SUPPL-2 Unichem Labeling Approved Olopatadine Hydrochloride ANDA #208637 Olopatadine Hydrochloride Solution/Drops; Ophthalmic SUPPL-1 Watson Labs Inc Labeling Approved Latisse NDA #213895 Bimatoprost Injectable; Injection ORIG-1 Xellia Pharms Aps Type 5 - New Formulation or New Manufacturer Approved Topiramate ANDA #215414 Topiramate Tablet; Oral ORIG-1 Ascent 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