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Generated: December 18, 2018

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Details for New Drug Application (NDA): 078745

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NDA 078745 describes RAMIPRIL, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Apotex, Aurobindo Pharma Ltd, Chartwell Molecular, Cipla, Dr Reddys Labs Ltd, 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-three 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-four suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 078745
Tradename:RAMIPRIL
Applicant:Chartwell Molecular
Ingredient:ramipril
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078745
Medical Subject Heading (MeSH) Categories for 078745
Suppliers and Packaging for NDA: 078745
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 078745 ANDA Camber Pharmaceuticals 31722-271 31722-271-01 24 BOTTLE in 1 CASE (31722-271-01) > 100 CAPSULE in 1 BOTTLE
RAMIPRIL ramipril CAPSULE;ORAL 078745 ANDA Camber Pharmaceuticals 31722-271 31722-271-05 24 BOTTLE in 1 CASE (31722-271-05) > 500 CAPSULE in 1 BOTTLE

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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