Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214717
Company: EPIC PHARMA LLC

Products on ANDA 214717

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	AB	No	No
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214717

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214717

URSODIOL

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	214717	EPIC PHARMA LLC
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	090801	GLENMARK PHARMS LTD
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	202540	PH HEALTH
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	213504	STRIDES PHARMA
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	211145	ZYDUS LIFESCIENCES

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	214717	EPIC PHARMA LLC
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	090801	GLENMARK PHARMS LTD
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	202540	PH HEALTH
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	213504	STRIDES PHARMA
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	211145	ZYDUS LIFESCIENCES