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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201573
Company: ANCHEN PHARMS

Products on ANDA 201573

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201573

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/18/2013	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201573Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2020	SUPPL-10	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/06/2015	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 201573

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201573Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 201573

FENOFIBRIC ACID

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 PHARMS LTD
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

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 PHARMS LTD
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

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