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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Colorcon
Teva
Queensland Health
Accenture
AstraZeneca
Chubb
Argus Health
Baxter

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078832

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NDA 078832 describes RAMIPRIL, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Invagen Pharms, Lupin, Ranbaxy Labs Ltd, Teva Pharms, Watson Labs, West-ward Pharms Int, Yaopharma Co Ltd, Zydus Pharms Usa, Apotex Inc, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in seventeen NDAs. It is available from thirty-four 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. Thirty-five suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 078832
Tradename:RAMIPRIL
Applicant:Zydus Pharms Usa
Ingredient:ramipril
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078832
Medical Subject Heading (MeSH) Categories for 078832
Suppliers and Packaging for NDA: 078832
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 078832 ANDA American Health Packaging 60687-321 N 60687-321-21
RAMIPRIL ramipril CAPSULE;ORAL 078832 ANDA American Health Packaging 60687-332 N 60687-332-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Sep 2, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Sep 2, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Sep 2, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Argus Health
Teva
Boehringer Ingelheim
Julphar
Colorcon
Fish and Richardson
Covington
McKesson

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