Details for New Drug Application (NDA): 078052
✉ Email this page to a colleague
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 078052
Tradename: | FOSPHENYTOIN SODIUM |
Applicant: | Fresenius Kabi Usa |
Ingredient: | fosphenytoin sodium |
Patents: | 0 |
Pharmacology for NDA: 078052
Suppliers and Packaging for NDA: 078052
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078052 | ANDA | Fresenius Kabi USA, LLC | 63323-403 | 63323-403-02 | 25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01) |
FOSPHENYTOIN SODIUM | fosphenytoin sodium | INJECTABLE;INJECTION | 078052 | ANDA | Fresenius Kabi USA, LLC | 63323-403 | 63323-403-10 | 10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG PHENYTOIN NA/ML | ||||
Approval Date: | Aug 6, 2007 | TE: | AP | RLD: | No |
Complete Access Available with Subscription