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Details for New Drug Application (NDA): 078251

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NDA 078251 describes CARVEDILOL, which is a drug marketed by Zydus Pharms Usa Inc, Mylan, Lupin, Sandoz, Aurobindo Pharma, Pliva Hrvatska Doo, Sun Pharm Inds Inc, Dr Reddys Labs Ltd, Glenmark Generics, Apotex Inc, Teva, Cipla Ltd, Taro, Beximco Usa, Wockhardt Ltd, Hikma, and Sun Pharm Inds Ltd, and is included in seventeen NDAs. It is available from fifty suppliers. Additional details are available on the CARVEDILOL profile page.

The generic ingredient in CARVEDILOL is carvedilol. There are thirty-five drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the carvedilol profile page.

Summary for NDA: 078251

Glenmark Generics
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078251

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 078251 ANDA Major Pharmaceuticals 0904-6096 0904-6096-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-6096-61)
TABLET;ORAL 078251 ANDA Major Pharmaceuticals 0904-6097 0904-6097-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-6097-61)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3.125MG
Approval Date:Sep 5, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6.25MG
Approval Date:Sep 5, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Sep 5, 2007TE:ABRLD:No

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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 verifification 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.