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Serving leading biopharmaceutical companies globally:

Dow
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Johnson and Johnson
Covington
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McKinsey
Chubb
Medtronic
US Department of Justice
Mallinckrodt

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077522

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NDA 077522 describes TRANDOLAPRIL, which is a drug marketed by Aurobindo Pharma, Cipla, 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 eight 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. Four suppliers are listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.
Summary for 077522
Tradename:TRANDOLAPRIL
Applicant:Lupin
Ingredient:trandolapril
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077522
Suppliers and Packaging for NDA: 077522
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANDOLAPRIL trandolapril TABLET;ORAL 077522 ANDA Carilion Materials Management 68151-0757 N 68151-0757-0
TRANDOLAPRIL trandolapril TABLET;ORAL 077522 ANDA Lupin Pharmaceuticals, Inc. 68180-566 N 68180-566-01

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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