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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 078438


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NDA 078438 describes TRANDOLAPRIL, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Pharmobedient, Senores Pharms, Teva Pharms, Watson Labs, and Glenmark Pharms Ltd, 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 078438
Tradename:TRANDOLAPRIL
Applicant:Aurobindo Pharma
Ingredient:trandolapril
Patents:0
Pharmacology for NDA: 078438
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Suppliers and Packaging for NDA: 078438
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANDOLAPRIL trandolapril TABLET;ORAL 078438 ANDA Rising Pharma Holdings, Inc. 57237-089 57237-089-01 100 TABLET in 1 BOTTLE (57237-089-01)
TRANDOLAPRIL trandolapril TABLET;ORAL 078438 ANDA Rising Pharma Holdings, Inc. 57237-090 57237-090-01 100 TABLET in 1 BOTTLE (57237-090-01)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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