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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200264
Company: IMPAX LABS INC

Products on ANDA 200264

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200264

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/07/2016	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/29/2021	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/23/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/23/2019	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200264

FENOFIBRIC ACID

CAPSULE, DELAYED RELEASE;ORAL; EQ 45MG FENOFIBRIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200920	ACTAVIS ELIZABETH
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	208705	ALEMBIC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	201573	ANCHEN PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212598	AUROBINDO PHARMA LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	211626	GRAVITI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200264	IMPAX LABS INC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200750	LUPIN LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	213450	MICRO LABS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210469	TWI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212562	YICHANG HUMANWELL
TRILIPIX	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022224	ABBVIE

CAPSULE, DELAYED RELEASE;ORAL; EQ 135MG FENOFIBRIC ACID
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200920	ACTAVIS ELIZABETH
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	208705	ALEMBIC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	201573	ANCHEN PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212598	AUROBINDO PHARMA LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	211626	GRAVITI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200264	IMPAX LABS INC
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	200750	LUPIN LTD
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	213450	MICRO LABS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	210469	TWI PHARMS
FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	212562	YICHANG HUMANWELL
TRILIPIX	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022224	ABBVIE

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