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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078191


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NDA 078191 describes RAMIPRIL, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Apotex, Aurobindo Pharma Ltd, Chartwell Molecular, Cipla, Dr Reddys Labs Ltd, Hikma Pharms, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, Yaopharma Co Ltd, Zydus Pharms Usa, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from twenty-one 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. Twenty-two suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 078191
Tradename:RAMIPRIL
Applicant:Dr Reddys Labs Ltd
Ingredient:ramipril
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078191
Medical Subject Heading (MeSH) Categories for 078191
Suppliers and Packaging for NDA: 078191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 078191 ANDA Dr. Reddy's Laboratories Limited 55111-438 55111-438-01 100 CAPSULE in 1 BOTTLE (55111-438-01)
RAMIPRIL ramipril CAPSULE;ORAL 078191 ANDA Dr. Reddy's Laboratories Limited 55111-438 55111-438-05 500 CAPSULE in 1 BOTTLE (55111-438-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Jun 18, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 18, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 18, 2008TE:ABRLD:No

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