Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217732
Company: CREEKWOOD PHARMS

Products on ANDA 217732

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOFIBRATE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	AB	No	No
FENOFIBRATE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217732

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/07/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/21/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217732

FENOFIBRATE

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	No	AB	217732	CREEKWOOD PHARMS
FENOFIBRATE	FENOFIBRATE	40MG	TABLET;ORAL	Prescription	No	AB	204475	MYLAN PHARMS INC

TABLET;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	No	AB	217732	CREEKWOOD PHARMS
FENOFIBRATE	FENOFIBRATE	120MG	TABLET;ORAL	Prescription	No	AB	204475	MYLAN PHARMS INC