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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090697

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NDA 090697 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 090697
Tradename:RAMIPRIL
Applicant:Zydus Pharms Usa Inc
Ingredient:ramipril
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090697
Medical Subject Heading (MeSH) Categories for 090697
Suppliers and Packaging for NDA: 090697
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril TABLET;ORAL 090697 ANDA Cadila Healthcare Limited 65841-699 N 65841-699-01
RAMIPRIL ramipril TABLET;ORAL 090697 ANDA Cadila Healthcare Limited 65841-699 N 65841-699-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.25MG
Approval Date:Sep 24, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 24, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Sep 24, 2009TE:RLD:No

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