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Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200750

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NDA 200750 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Impax Labs Inc, Lupin Ltd, and Mylan Pharms Inc, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the FENOFIBRIC ACID profile page.

The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

Summary for 200750

Tradename:	FENOFIBRIC ACID
Applicant:	Lupin Ltd
Ingredient:	choline fenofibrate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 200750

Suppliers and Packaging for NDA: 200750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	200750	ANDA	Lupin Pharmaceuticals, Inc.	68180-128	N	68180-128-01
FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	200750	ANDA	Lupin Pharmaceuticals, Inc.	68180-128	N	68180-128-02

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 45MG FENOFIBRIC ACID
Approval Date:	Dec 4, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 135MG FENOFIBRIC ACID
Approval Date:	Dec 4, 2013	TE:	AB	RLD:	No

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