Details for New Drug Application (NDA): 078765
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NDA 078765 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 078765
| Tradename: | FOSPHENYTOIN SODIUM |
| Applicant: | Hikma Farmaceutica |
| Ingredient: | fosphenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 078765
Suppliers and Packaging for NDA: 078765
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078765 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9782 | 0143-9782-10 | 10 VIAL in 1 PACKAGE (0143-9782-10) / 10 mL in 1 VIAL (0143-9782-01) |
| FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078765 | ANDA | West-Ward Pharmaceuticals Corp | 0143-9788 | 0143-9788-25 | 25 VIAL in 1 PACKAGE (0143-9788-25) / 2 mL in 1 VIAL (0143-9788-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG PHENYTOIN NA/ML | ||||
| Approval Date: | Dec 2, 2009 | TE: | AP | RLD: | No | ||||
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