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May 11, 2021

S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals

Docket Number: FDA-2017-D-5138 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purpose of this guidance is […]
May 10, 2021

Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions

Summary Company Announcement Date: May 07, 2021 FDA Publish Date: May 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to improper storage […]
May 10, 2021

FDA Updates and Press Announcements on NDMA in Ranitidine (Zantac)

Update [2/27/2020] FDA is alerting patients and health care professionals to American Health Packaging’s voluntary recall of ranitidine tablets (150 mg), manufactured by Amneal Pharmaceuticals, LLC. […]
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 […]
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