Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204475
Company: MYLAN PHARMS INC

Products on ANDA 204475

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204475

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2016	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204475Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/04/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/04/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/04/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 204475

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/23/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204475Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 204475

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	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	204475	MYLAN PHARMS INC