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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 | Phenytoin Oral Suspension, VistaPharm, Approval | Phenytoin Sodium Extended Capsules, Taro Pharma, Approval | Phenytoin Sodium Injection, Hikma Farmaceutica, Approval | Phenytoin Sodium Extended Capsules, Sun Pharma, Approval | Phenytoin Sodium Injection, PharmaForce Inc., Approval | Extended Phenytoin Sodium, Capsule, Wockhardt, Approval | Phenytoin Sodium Extended Capsules, Wockhardt Inc., Approval | Extended Phenytoin Sodium (phenytoin sodium, extended) Capsules, Sun Pharmaceutical Industries, Ltd., Approval | Phenytoin Sodium Extended-Release Capsules, Amneal Pharmaceuticals of NY, Approval | Dilantin-125 (phenytoin) Oral Suspension, Pfizer, Inc., Labeling Revision | Dilantin (phenytoin) Oral Suspension, Pfizer, Inc., Labeling Revision | Dilantin (phenytoin) Oral Solution, Pfizer, Inc., Labeling Revision | Dilantin (phenytoin sodium) Injection, Pfizer Inc., Labeling Revision | Dilantin-125 (phenytoin) Oral Suspension, Pfizer Inc., Labeling Revision | Dilantin-125 (phenytoin) Oral Suspension, Pfizer Inc., Labeling Revision
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