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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091555

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NDA 091555 describes EPTIFIBATIDE, which is a drug marketed by Accord Hlthcare, Akorn, Amneal Pharms, Aurobindo Pharma Ltd, Sagent Pharms, and Teva Pharms Usa, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the EPTIFIBATIDE profile page.

The generic ingredient in EPTIFIBATIDE is eptifibatide. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the eptifibatide profile page.

Summary for 091555

Tradename:	EPTIFIBATIDE
Applicant:	Teva Pharms Usa
Ingredient:	eptifibatide
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 091555

Physiological Effect	Decreased Platelet Aggregation

Suppliers and Packaging for NDA: 091555

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EPTIFIBATIDE	eptifibatide	INJECTABLE;INJECTION	091555	ANDA	Teva Parenteral Medicines, Inc.	0703-1179	N	0703-1179-01

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	75MG/100ML
Approval Date:	Jun 5, 2015	TE:		RLD:	No

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Serving hundreds of leading biopharmaceutical companies globally:

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