Details for New Drug Application (NDA): 084349
NDA 084349 describes DILANTIN, which is a drug marketed by Viatris, Parke Davis, and Pharmacia, and is included in four NDAs. It is available from five suppliers. Additional details are available on the DILANTIN profile page.
The generic ingredient in DILANTIN is phenytoin. There are two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
The generic ingredient in DILANTIN is phenytoin. There are two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
Summary for 084349
| Tradename: | DILANTIN |
| Applicant: | Viatris |
| Ingredient: | phenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 084349
Suppliers and Packaging for NDA: 084349
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILANTIN | phenytoin sodium | CAPSULE;ORAL | 084349 | ANDA | Viatris Specialty LLC | 58151-110 | 58151-110-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01) |
| DILANTIN | phenytoin sodium | CAPSULE;ORAL | 084349 | ANDA | Viatris Specialty LLC | 58151-110 | 58151-110-10 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG EXTENDED | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG EXTENDED | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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