Safety Labeling Change Orders

3/14/2025ANDA-070765, ANDA-070766Chlordiazepoxide and Amitriptyline HydrochlorideANDA REPOSITORY, LLCArchive4/28/2023NDA-019758Clozaril (Clozapine)HERITAGE LIFE SCIENCES BARBADOS INCArchive9/20/2021NDA-018936Prozac (Fluoxetine Hydrochloride)ELI LILLY AND...

Guidance for Industry

Docket Number: FDA-2023-D-1955 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3)...

Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination

Summary Company Announcement Date: September 05, 2025 FDA Publish Date: September 08, 2025 Product Type: Food & Beverages Cheese/Cheese Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with-Listeria...