Details for New Drug Application (NDA): 078791
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NDA 078791 describes DIVALPROEX SODIUM, which is a drug marketed by Ajanta Pharma Ltd, Dr Reddys Labs Ltd, Rising, Teva Pharms Usa, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Invatech, Lupin, Mylan, Norvium Bioscience, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, Utopic Pharms, and Wockhardt, and is included in thirty-six NDAs. It is available from forty suppliers. Additional details are available on the DIVALPROEX SODIUM profile page.
The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are eighteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.
Summary for 078791
| Tradename: | DIVALPROEX SODIUM |
| Applicant: | Impax Labs |
| Ingredient: | divalproex sodium |
| Patents: | 0 |
Pharmacology for NDA: 078791
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 078791
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078791 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-201 | 71610-201-53 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-53) |
| DIVALPROEX SODIUM | divalproex sodium | TABLET, EXTENDED RELEASE;ORAL | 078791 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-201 | 71610-201-60 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71610-201-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 250MG VALPROIC ACID | ||||
| Approval Date: | May 6, 2009 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG VALPROIC ACID | ||||
| Approval Date: | Aug 4, 2009 | TE: | RLD: | No | |||||
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