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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077626

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NDA 077626 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, Sandoz, Teva Pharms, Watson Labs, West-ward Pharms Int, 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 077626

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077626

Medical Subject Heading (MeSH) Categories for 077626

Suppliers and Packaging for NDA: 077626

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAMIPRIL ramipril CAPSULE;ORAL 077626 ANDA PD-Rx Pharmaceuticals, Inc. 43063-303 43063-303-90 90 CAPSULE in 1 BOTTLE, PLASTIC (43063-303-90)
RAMIPRIL ramipril CAPSULE;ORAL 077626 ANDA PD-Rx Pharmaceuticals, Inc. 43063-303 43063-303-30 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-303-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Jun 9, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 9, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 9, 2008TE:ABRLD:No


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