Details for New Drug Application (NDA): 084427
✉ Email this page to a colleague
NDA 084427 describes DILANTIN, which is a drug marketed by Viatris, Parke Davis, and Pharmacia, and is included in four NDAs. It is available from three suppliers. Additional details are available on the DILANTIN profile page.
The generic ingredient in DILANTIN is phenytoin. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
The generic ingredient in DILANTIN is phenytoin. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
Summary for 084427
| Tradename: | DILANTIN |
| Applicant: | Pharmacia |
| Ingredient: | phenytoin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 084427
Medical Subject Heading (MeSH) Categories for 084427
Suppliers and Packaging for NDA: 084427
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILANTIN | phenytoin | TABLET, CHEWABLE;ORAL | 084427 | ANDA | Parke-Davis Div of Pfizer Inc | 0071-0007 | 0071-0007-24 | 100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24) |
| DILANTIN | phenytoin | TABLET, CHEWABLE;ORAL | 084427 | ANDA | Parke-Davis Div of Pfizer Inc | 0071-0007 | 0071-0007-40 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0071-0007-40) / 1 TABLET, CHEWABLE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
