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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090715
Company: VALEANT PHARMS NORTH

Products on ANDA 090715

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	AB	No	No
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090715

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2012	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/01/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/05/2012	SUPPL-5			Label is not available on this site.
10/06/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090715

FENOFIBRATE

TABLET;ORAL; 48MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	210476	ALEMBIC
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	209951	AMNEAL
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	205118	AUROBINDO PHARMA
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	208476	AUSTARPHARMA
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	208709	CIPLA
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	211122	GRAVITI PHARMS
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	204598	HETERO LABS LTD III
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	090856	LUPIN LTD
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	202856	MYLAN PHARMS INC
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	211080	PRINSTON INC
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	200884	SUN PHARM
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	090715	VALEANT PHARMS NORTH
TRICOR	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	Yes	AB	021656	ABBVIE

TABLET;ORAL; 145MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	210476	ALEMBIC
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	209951	AMNEAL
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	205118	AUROBINDO PHARMA
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	208476	AUSTARPHARMA
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	208709	CIPLA
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	211122	GRAVITI PHARMS
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	204598	HETERO LABS LTD III
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	090856	LUPIN LTD
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	202856	MYLAN PHARMS INC
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	211080	PRINSTON INC
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	200884	SUN PHARM
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	090715	VALEANT PHARMS NORTH
TRICOR	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	Yes	AB	021656	ABBVIE

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