Details for New Drug Application (NDA): 040573
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NDA 040573 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 ten 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-four 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-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 040573
| Tradename: | PHENYTOIN SODIUM |
| Applicant: | Acella |
| Ingredient: | phenytoin sodium |
| Patents: | 0 |
Pharmacology for NDA: 040573
Suppliers and Packaging for NDA: 040573
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 040573 | ANDA | Acella Pharmaceuticals, LLC | 42192-614 | 42192-614-10 | 10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL |
| PHENYTOIN SODIUM | phenytoin sodium | INJECTABLE;INJECTION | 040573 | ANDA | Acella Pharmaceuticals, LLC | 42192-614 | 42192-614-30 | 10 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Sep 13, 2006 | TE: | AP | RLD: | No | ||||
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