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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077256


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NDA 077256 describes TRANDOLAPRIL, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Mylan, Teva Pharms, Watson Labs, and Glenmark Generics, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the TRANDOLAPRIL profile page.

The generic ingredient in TRANDOLAPRIL is trandolapril; verapamil hydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.
Summary for 077256
Tradename:TRANDOLAPRIL
Applicant:Epic Pharma Llc
Ingredient:trandolapril
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Jun 12, 2007TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Jun 12, 2007TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4MG
Approval Date:Jun 12, 2007TE:RLD:No

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