Details for New Drug Application (NDA): 214926
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NDA 214926 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, and Wockhardt, and is included in fourteen NDAs. It is available from six suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.
The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
Summary for 214926
| Tradename: | FOSPHENYTOIN SODIUM |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | fosphenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 214926
Suppliers and Packaging for NDA: 214926
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 214926 | ANDA | Gland Pharma Limited | 68083-460 | 68083-460-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-460-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01) |
| FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 214926 | ANDA | Gland Pharma Limited | 68083-461 | 68083-461-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG PHENYTOIN NA/ML | ||||
| Approval Date: | Oct 13, 2023 | TE: | AP | RLD: | No | ||||
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