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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 077100


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NDA 077100 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.
Summary for 077100
Tradename:DIVALPROEX SODIUM
Applicant:Zydus Pharms Usa Inc
Ingredient:divalproex sodium
Patents:0
Pharmacology for NDA: 077100
Suppliers and Packaging for NDA: 077100
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077100 ANDA Zydus Lifesciences Limited 65841-634 65841-634-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (65841-634-01)
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 077100 ANDA Zydus Lifesciences Limited 65841-634 65841-634-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (65841-634-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Mar 5, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Mar 5, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Mar 5, 2009TE:ABRLD:No

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