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Federal Trade Commission
Cerilliant
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Fish and Richardson
Daiichi Sankyo
Citi
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Julphar
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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:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Dec 4, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Dec 4, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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