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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 Roxane, Aurobindo Pharma Ltd, Cipla, Actavis Elizabeth, Sandoz, Apotex, Lupin, Zydus Pharms Usa, Invagen Pharms, Ranbaxy Labs Ltd, Watson Labs, Mylan Pharms Inc, Apotex Inc, Teva Pharms, Dr Reddys Labs Ltd, Accord Hlthcare 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-five suppliers are listed for this compound. Additional details are available on the ramipril profile page.

Summary for NDA: 078745

Invagen Pharms
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 078745

Suppliers and Packaging for NDA: 078745

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 078745 ANDA Camber Pharmaceuticals 31722-271 31722-271-01 24 BOTTLE in 1 CASE (31722-271-01) > 100 CAPSULE in 1 BOTTLE
CAPSULE;ORAL 078745 ANDA Camber Pharmaceuticals 31722-271 31722-271-05 24 BOTTLE in 1 CASE (31722-271-05) > 500 CAPSULE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1.25MG
Approval Date:Jun 18, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2.5MG
Approval Date:Jun 18, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jun 18, 2008TE:ABRLD:No

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