Details for New Drug Application (NDA): 213834
NDA 213834 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Lupin, Mankind Pharma, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Unichem, Wockhardt, and Wockhardt Usa, and is included in thirteen 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 is one drug master file entry for this compound. Twenty-four 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 is one drug master file entry for this compound. Twenty-four 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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