2007P-0216: Determine that an Additional Dosage of Deferoxamine Mesylate for Injection, USP is Suitable for an Abbreviated New Drug Application (ANDA)

CP1

Petition (pdf)

Deferoxamine Mesylate for Injection USP, Bedfor Laboratories 2007 (Copyrighted Material)

Search: Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (pdf)