Types of DMFs

Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation; or Drug Product The Generic Drug User Fee Amendments (GDUFA) include provisions for DMF fees, a completeness assessment, and communications with DMF holders for Type II DMFs...

Cronus Pharma LLC initiating Voluntary Recall for (Dexased™ -Aspen and Dexmedvet™ -Cronus Pharma LLC) of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL For Veterinary Use Due to Presence of Particulate Matter

Summary Company Announcement Date: April 23, 2025 FDA Publish Date: April 24, 2025 Product Type: Animal & Veterinary Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Cronus Pharma LLC Brand Name: Brand Name(s)...