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… Dilantin-125 (phenytoin) Suspension, Pfizer NDA 8-762/S-031 3/24/03 3/26/03 Dilantin-125 (phenytoin) Suspension & Dilantin (Phenytoin Sodium) Injection, USP, Pfizer NDA 8-762/S-020, 021, 022 & 026 & 10-151/S-022, 029, 030, 032, 033 & 034 Extended Phenytoin Sodium Capsules USP, 200 & 300 mg, Mylan Phenytoin Suspension USP, 125 mg/5 mL, Morton Grove ANDA 40-420 4/19/02 4/9/03 Phenytoin Suspension USP, 125 mg/5 mL, UDL , ANDA 40-342 1/31/01 2/27/01 Phenytoin Sodium Capsules Extended USP, 100 mg. Mylan ANDA 40-298 PHENYTOIN Suspension; 125MG/5ML PHENYTOIN ALPHARMA 040420 PHENYTOIN Suspension; 125MG/5ML PHENTYTOIN Morton Grove 008762 PHENYTOIN Suspension; 125MG/5ML DILANTIN-125 PARKE DAVIS 040342 PHENYTOIN Suspension; 125MG/5ML PHENYTOIN VISTAPHARM 084427 PHENYTOIN Tablet, Chewable; 50MG DILANTIN PFIZER 084307 PHENYTOIN SODIUM Injection 50MG/ML PHENYTOIN ELKINS SINN 040435 PHENYTOIN SODIUM, EXTENDED Capsule; 100MG EXTENDED PHENYTOIN SODIUM Barr 040298 PHENYTOIN SODIUM, EXTENDED Capsule; 100MG EXTENDED PHENYTOIN SODIUM Mylan 040298 PHENYTOIN SODIUM, EXTENDED Capsule; 200MG PHENYTEK Mylan 040298 PHENYTOIN SODIUM, EXTENDED Capsule; 300MG PHENYTEK Mylan 084349 PHENYTOIN SODIUM, EXTENDED Capsule; 100MG DILANTIN PARKE DAVIS 084349 PHENYTOIN SODIUM, EXTENDED Capsule; 30MG DILANTIN PARKE DAVIS 080259 PHENYTOIN SODIUM, PROMPT Capsule; 100MG PROMPT PHENYTOIN SODIUM Ivax Phenytoin Oral Suspension USP, Taro Pharmaceutical   For the latest approval information, locate this drug using this index.