Details for New Drug Application (NDA): 076539
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NDA 076539 describes VALPROATE SODIUM, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Norvium Bioscience, and Sagent, and is included in four NDAs. It is available from three suppliers. Additional details are available on the VALPROATE SODIUM profile page.
The generic ingredient in VALPROATE SODIUM is valproate sodium. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.
The generic ingredient in VALPROATE SODIUM is valproate sodium. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.
Summary for 076539
| Tradename: | VALPROATE SODIUM |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | valproate sodium |
| Patents: | 0 |
Pharmacology for NDA: 076539
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 076539
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 076539 | ANDA | Fresenius Kabi USA, LLC | 63323-494 | 63323-494-16 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-16) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-41) |
| VALPROATE SODIUM | valproate sodium | INJECTABLE;INJECTION | 076539 | ANDA | Fresenius Kabi USA, LLC | 63323-494 | 63323-494-05 | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-494-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 100MG BASE/ML | ||||
| Approval Date: | Jun 26, 2003 | TE: | AP | RLD: | No | ||||
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