Details for New Drug Application (NDA): 008762
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NDA 008762 describes DILANTIN-30, which is a drug marketed by Viatris and is included in one NDA. It is available from two suppliers. Additional details are available on the DILANTIN-30 profile page.
The generic ingredient in DILANTIN-30 is phenytoin. There are twenty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
The generic ingredient in DILANTIN-30 is phenytoin. There are twenty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
Summary for 008762
| Tradename: | DILANTIN-30 |
| Applicant: | Viatris |
| Ingredient: | phenytoin |
| Patents: | 0 |
Pharmacology for NDA: 008762
Medical Subject Heading (MeSH) Categories for 008762
Suppliers and Packaging for NDA: 008762
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DILANTIN-125 | phenytoin | SUSPENSION;ORAL | 008762 | NDA | Viatris Specialty LLC | 58151-115 | 58151-115-35 | 1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC |
| DILANTIN-125 | phenytoin | SUSPENSION;ORAL | 008762 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-0531 | 59762-0531-2 | 1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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