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Generated: July 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077470

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NDA 077470 describes RAMIPRIL, which is a drug marketed by West-ward Pharms Int, 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, 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 NDA: 077470

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

Pharmacology for NDA: 077470

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors

Suppliers and Packaging for NDA: 077470

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RAMIPRIL	ramipril	CAPSULE;ORAL	077470	ANDA	Lake Erie Medical DBA Quality Care Products LLC	35356-893	35356-893-30	30 CAPSULE in 1 BOTTLE (35356-893-30)
RAMIPRIL	ramipril	CAPSULE;ORAL	077470	ANDA	Lake Erie Medical DBA Quality Care Products LLC	35356-893	35356-893-60	60 CAPSULE in 1 BOTTLE (35356-893-60)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	1.25MG
Approval Date:	Jun 18, 2008	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	2.5MG
Approval Date:	Jun 18, 2008	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Jun 18, 2008	TE:	AB	RLD:	No

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