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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 078251


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NDA 078251 describes CARVEDILOL, which is a drug marketed by Aurobindo Pharma, Beximco Usa, Chartwell Molecular, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hikma, Lupin, MLV, Mylan, Pliva Hrvatska Doo, Rubicon, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Zydus Pharms Usa Inc, Impax Labs Inc, and Sun Pharm Industries, and is included in nineteen NDAs. It is available from forty-two suppliers. Additional details are available on the CARVEDILOL profile page.

The generic ingredient in CARVEDILOL is carvedilol phosphate. There are thirty-seven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 078251
Tradename:CARVEDILOL
Applicant:Glenmark Pharms Ltd
Ingredient:carvedilol
Patents:0
Suppliers and Packaging for NDA: 078251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARVEDILOL carvedilol TABLET;ORAL 078251 ANDA Major Pharmaceuticals 0904-7305 0904-7305-61 100 BLISTER PACK in 1 CARTON (0904-7305-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
CARVEDILOL carvedilol TABLET;ORAL 078251 ANDA Major Pharmaceuticals 0904-7306 0904-7306-61 100 BLISTER PACK in 1 CARTON (0904-7306-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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