Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076635
Company: SUN PHARM INDS LTD

Products on ANDA 076635

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	Prescription	None	No	No
FENOFIBRATE	FENOFIBRATE	160MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076635

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076635ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/13/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/18/2018	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 076635

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

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