Details for New Drug Application (NDA): 078765
NDA 078765 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, Hikma Farmaceutica, Hospira, Pharmobedient, Sun Pharm, and Wockhardt Bio Ag, and is included in fourteen NDAs. It is available from seven suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.
The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There is one drug master file entry for this compound. Eight 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 is one drug master file entry for this compound. Eight 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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