Details for New Drug Application (NDA): 020450
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The generic ingredient in CEREBYX 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 020450
Tradename: | CEREBYX |
Applicant: | Parke Davis |
Ingredient: | fosphenytoin sodium |
Patents: | 0 |
Pharmacology for NDA: 020450
Suppliers and Packaging for NDA: 020450
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-5471 | 0069-5471-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0069-5471-02) / 2 mL in 1 VIAL, SINGLE-DOSE (0069-5471-01) |
CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-5474 | 0069-5474-02 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG PHENYTOIN NA/ML | ||||
Approval Date: | Aug 5, 1996 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 020450
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Parke Davis | CEREBYX | fosphenytoin sodium | INJECTABLE;INJECTION | 020450-001 | Aug 5, 1996 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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