Last Updated: May 12, 2026

Details for New Drug Application (NDA): 078508


✉ Email this page to a colleague

« Back to Dashboard


NDA 078508 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 078508
Tradename:TRANDOLAPRIL
Applicant:Epic Pharma
Ingredient:trandolapril
Patents:0
Pharmacology for NDA: 078508
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
© Copyright 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
 NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links