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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076520
Company: MYLAN

Products on ANDA 076520

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	AB	No	No
FENOFIBRATE	FENOFIBRATE	107MG	TABLET;ORAL	Discontinued	None	No	No
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076520

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2005	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
06/03/2021	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
09/23/2019	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
09/23/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/23/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
09/23/2019	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/23/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
02/14/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/22/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/02/2010	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/03/2010	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
10/25/2007	SUPPL-2	Labeling		Label is not available on this site.
10/25/2007	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 076520

FENOFIBRATE

TABLET;ORAL; 54MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	210138	AJANTA PHARMA LTD
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	209950	AMNEAL
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	216798	AUROBINDO PHARMA
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	207803	AUSTARPHARMA
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	209660	CHARTWELL RX
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	210670	DR REDDYS
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	210606	GRAVITI PHARMS
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	076509	IMPAX LABS
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	204019	LUPIN LTD
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	213864	MANKIND PHARMA
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	076520	MYLAN
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	076433	RHODES PHARMS
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	076635	SUN PHARM INDS LTD
FENOFIBRATE	FENOFIBRATE	54MG	TABLET;ORAL	Prescription	No	AB	218548	YICHANG HUMANWELL

TABLET;ORAL; 160MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	210138	AJANTA PHARMA LTD
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	209950	AMNEAL
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	216798	AUROBINDO PHARMA
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	207803	AUSTARPHARMA
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	209660	CHARTWELL RX
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	210670	DR REDDYS
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	210606	GRAVITI PHARMS
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	076509	IMPAX LABS
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	204019	LUPIN LTD
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	213864	MANKIND PHARMA
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	076520	MYLAN
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	076433	RHODES PHARMS
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	076635	SUN PHARM INDS LTD
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	No	AB	218548	YICHANG HUMANWELL

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