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Last Updated: November 4, 2024

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, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Cipla, Corepharma, Dr Reddys Labs Ltd, 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 eighteen 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. Nineteen 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
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 Zydus Lifesciences Limited 65841-655 65841-655-01 100 CAPSULE in 1 BOTTLE (65841-655-01)
RAMIPRIL ramipril CAPSULE;ORAL 078832 ANDA Zydus Lifesciences Limited 65841-655 65841-655-05 500 CAPSULE in 1 BOTTLE (65841-655-05)

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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