An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208709
Company: CIPLA

Products on ANDA 208709

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 208709

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2016	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-11	Labeling-Package Insert		Label is not available on this site.
05/27/2022	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/19/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208709

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	BOSTAL
FENOFIBRATE	FENOFIBRATE	48MG	TABLET;ORAL	Prescription	No	AB	208709	CIPLA
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	210248	MACLEODS PHARMS 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	211122	RISING

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	BOSTAL
FENOFIBRATE	FENOFIBRATE	145MG	TABLET;ORAL	Prescription	No	AB	208709	CIPLA
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	210248	MACLEODS PHARMS 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	211122	RISING

Top