Details for New Drug Application (NDA): 213834
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NDA 213834 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, and Wockhardt Usa, and is included in eleven NDAs. It is available from seventeen suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.
The generic ingredient in EXTENDED PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
The generic ingredient in EXTENDED PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 213834
| Tradename: | EXTENDED PHENYTOIN SODIUM |
| Applicant: | Unichem |
| Ingredient: | phenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 213834
Suppliers and Packaging for NDA: 213834
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXTENDED PHENYTOIN SODIUM | phenytoin sodium | CAPSULE;ORAL | 213834 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-379 | 29300-379-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-01) |
| EXTENDED PHENYTOIN SODIUM | phenytoin sodium | CAPSULE;ORAL | 213834 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-379 | 29300-379-05 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 100MG EXTENDED | ||||
| Approval Date: | Oct 13, 2022 | TE: | RLD: | No | |||||
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