Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Dexmethylphenidate HCl Tablets Celgene NDA 21-278 Focalin (Dexmethylphenidate HCl) Tablets, 2.5, 5 & 10 mg Celgene NDA 21-278 TRADENAME (dexmethylphenidate HCl) 2.5 mg, 5 mg, and 10 mg Tablets, Celgene NDA 21-278   For the latest approval information, locate this drug using this index.