Details for New Drug Application (NDA): 084307
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NDA 084307 describes PHENYTOIN SODIUM, which is a drug marketed by Aurobindo Pharma, Pharmeral, Watson Labs, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.
The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 084307
| Tradename: | PHENYTOIN SODIUM |
| Applicant: | Hikma |
| Ingredient: | phenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 084307
Suppliers and Packaging for NDA: 084307
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 084307 | ANDA | Henry Schein, Inc. | 0404-9808 | 0404-9808-05 | 1 VIAL in 1 BAG (0404-9808-05) / 5 mL in 1 VIAL |
| PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 084307 | ANDA | Henry Schein, Inc. | 0404-9932 | 0404-9932-02 | 1 VIAL in 1 BAG (0404-9932-02) / 2 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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