You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 076697


✉ Email this page to a colleague

« Back to Dashboard


NDA 076697 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Chartwell Rx, Novitium Pharma, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in thirty-four NDAs. It is available from thirty-eight suppliers. Additional details are available on the CARBAMAZEPINE profile page.

The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 076697
Tradename:CARBAMAZEPINE
Applicant:Nostrum Labs Inc
Ingredient:carbamazepine
Patents:0
Suppliers and Packaging for NDA: 076697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 076697 ANDA Nostrum Laboratories, Inc. 29033-004 29033-004-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-004-12)
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 076697 ANDA Nostrum Laboratories, Inc. 29033-019 29033-019-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29033-019-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:May 20, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:May 20, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:May 20, 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.