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Healthtrust
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Fish and Richardson
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Julphar
Cipla

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076697

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NDA 076697 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Wockhardt Bio Ag, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in eighteen NDAs. It is available from thirty 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-two suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 076697
Tradename:CARBAMAZEPINE
Applicant:Mylan Ireland Ltd
Ingredient:carbamazepine
Patents:0
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
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 N 29033-004-12
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 076697 ANDA Nostrum Laboratories, Inc. 29033-019 N 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

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Colorcon
Argus Health
Boehringer Ingelheim
Merck
AstraZeneca
Cerilliant
Fuji
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