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Last Updated: March 28, 2024

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, Anchen Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Invatech, Lupin, Mylan, Orbion Pharms, Prinston Inc, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher Smith Labs, Amneal Pharms, Amta, Annora Pharma, Cosette, Impax Labs, Lupin Ltd, Reddys, Unichem, and Wockhardt, and is included in thirty-six NDAs. It is available from thirty-nine 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 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 078791
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:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:May 6, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Aug 4, 2009TE:RLD:No

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