You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 18, 2024

Details for New Drug Application (NDA): 090554


✉ Email this page to a colleague

« Back to Dashboard


NDA 090554 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 090554
Tradename:DIVALPROEX SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:divalproex sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090554
Suppliers and Packaging for NDA: 090554
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090554 ANDA A-S Medication Solutions 50090-5842 50090-5842-0 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-5842-0)
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090554 ANDA Cardinal Health 107, LLC 55154-4679 55154-4679-0 10 BLISTER PACK in 1 BAG (55154-4679-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Apr 21, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Apr 21, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Apr 21, 2011TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.