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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 079116


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NDA 079116 describes RAMIPRIL, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Anda Repository, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Cipla, Corepharma, Hikma, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, Zydus Pharms Usa, Apotex, Natco Pharma, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from seventeen suppliers. Additional details are available on the RAMIPRIL profile page.

The generic ingredient in RAMIPRIL is ramipril. There are nineteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 079116
Tradename:RAMIPRIL
Applicant:Corepharma
Ingredient:ramipril
Patents:0
Pharmacology for NDA: 079116
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Medical Subject Heading (MeSH) Categories for 079116
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Suppliers and Packaging for NDA: 079116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 079116 ANDA GSMS, Incorporated 51407-707 51407-707-01 100 CAPSULE in 1 BOTTLE (51407-707-01)
RAMIPRIL ramipril CAPSULE;ORAL 079116 ANDA GSMS, Incorporated 51407-708 51407-708-01 100 CAPSULE in 1 BOTTLE (51407-708-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Jun 20, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 20, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 20, 2008TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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