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FENOFIBRIC ACID

ANDA

CHOLINE FENOFIBRATE | A200913 | PHARMOBEDIENT CONSULTING LLC

2 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

CORDEN PHARMA CHENOVECHOLINE FENOFIBRATE DRUG SUBSTANCE

DMF 209502007

OLON SPACHOLINE FENOFIBRATE

DMF 232682009

CURIA MISSOURI INCCHOLINE FENOFIBRATE

DMF 233902009

OLON SPACHOLINE FENOFIBRATE

DMF 234642010

ALIVUS LIFE SCIENCES LTDCHOLINE FENOFIBRATE

DMF 245242011

MOEHS IBERICA SLCHOLINE FENOFIBRATE

DMF 245402011

HARMAN FINOCHEM LTDCHOLINE FENOFIBRATE

DMF 282822014

ABBVIE INCInactiveCHOLINE FENOFIBRATE DRUG SUBSTANCE

DMF 208952007

ABBVIE INCInactiveCHOLINE FENOFIBRATE MINI-TABLET INTERMEDIATE

DMF 208962007

LUPIN LTDInactiveCHOLINE FENOFIBRATE

DMF 230482009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 28, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 45MG FENOFIBRIC ACID

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Mar 25, 2013

No patent or exclusivity listings for this strength.

#002 — EQ 135MG FENOFIBRIC ACID

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Mar 25, 2013