fbpx
May 10, 2021

Hurricane Season: Be Prepared

Image Español When gale-force winds start blowing and torrential rains raise water levels, you need to be ready. Power outages mean refrigerated food and medicine supplies […]
May 10, 2021

Covalon Technologies Inc. – 614350 – 05/06/2021

Product: Drugs Issuing Office: Center for Drug Evaluation and Research United States Date:               May 6, 2021 TO:                 Christopher Fredric, Senior Director, Regulatory Affairs RE:             […]
May 7, 2021

Jubilant Cadista Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, Due to Out-of-Specification Dissolution Test Results

Summary Company Announcement Date: July 23, 2019 FDA Publish Date: July 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to out of […]
May 7, 2021

Ophthalmic Dosage Form Questions

Introduction:ANDA NumberDate of SubmissionApplicant’s NameEstablished Name of the Drug ProductProprietary Name of the Drug Product (include date proposed)Labeling Submissions (proposed labeling pieces, e.g., container, carton, FPL, […]
May 7, 2021

Topical Dosage Form Questions

Introduction: ANDA Number Date of Submission Applicant’s Name Established Name of the Drug Product Proprietary Name of the Drug Product (include date proposed) Labeling Submissions (proposed […]
May 7, 2021

Disinfect & Shield – 613716 – 05/06/2021

Product: Drugs Recipient: Recipient Name Despo Caldwell Recipient Title CEO Disinfect & Shield 1616 Fountain View DriveHouston, TX 77057United States [email protected] Issuing Office: Center for Drug […]
May 7, 2021

Inhalation Dosage Form Questions

Introduction:ANDA NumberDate of SubmissionApplicant’s NameEstablished Name of the Drug ProductProprietary Name of the Drug Product (include date proposed)Labeling Submissions (proposed labeling pieces, e.g., container, carton, FPL, […]
May 7, 2021

LRB QBR for Transdermal Systems

INTRODUCTION:ANDA NumberDate of SubmissionApplicant’s NameEstablished Name of the Drug ProductProprietary Name of the Drug Product (include date proposed)Labeling Submissions QbR Questions: 1. What is the basis […]
May 7, 2021

List of Determinations Including Written Request

Drug Sponsor Determination Date Written Request and Related Documents Abatacept   BMS 2/14/2017  Acetaminophen Mallinckrodt 7/11/2016 Albuterol GlaxoSmithKline 8/27/2008 Alfuzosin Sanofi Aventis 9/7/2010 Aliskiren Noden Pharma DAC […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0