BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Merck
Harvard Business School
Argus Health
US Department of Justice
UBS
Federal Trade Commission
Julphar
Boehringer Ingelheim

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078508

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NDA 078508 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 078508
Tradename:TRANDOLAPRIL
Applicant:Epic Pharma
Ingredient:trandolapril
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078508
Suppliers and Packaging for NDA: 078508
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRANDOLAPRIL trandolapril TABLET;ORAL 078508 ANDA Epic Pharma, LLC 42806-052 42806-052-01 100 TABLET in 1 BOTTLE (42806-052-01)
TRANDOLAPRIL trandolapril TABLET;ORAL 078508 ANDA Epic Pharma, LLC 42806-052 42806-052-10 1000 TABLET in 1 BOTTLE (42806-052-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 18, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Jun 18, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 18, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
QuintilesIMS
Federal Trade Commission
Citi
UBS
Baxter
Accenture
Cipla

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