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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 202392


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NDA 202392 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the ramipril profile page.
Summary for 202392
Tradename:RAMIPRIL
Applicant:Accord Hlthcare
Ingredient:ramipril
Patents:0
Pharmacology for NDA: 202392
Medical Subject Heading (MeSH) Categories for 202392
Suppliers and Packaging for NDA: 202392
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 202392 ANDA Proficient Rx LP 63187-644 63187-644-30 30 CAPSULE in 1 BOTTLE (63187-644-30)
RAMIPRIL ramipril CAPSULE;ORAL 202392 ANDA Proficient Rx LP 63187-644 63187-644-60 60 CAPSULE in 1 BOTTLE (63187-644-60)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Apr 15, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Apr 15, 2014TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Apr 15, 2014TE:RLD:No

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