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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213504
Company: STRIDES PHARMA

Products on ANDA 213504

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 213504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2020	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
06/30/2023	SUPPL-3	Labeling-Patient Package Insert		Label is not available on this site.
06/09/2022	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213504

URSODIOL

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
URSO 250	URSODIOL	250MG	TABLET;ORAL	Prescription	Yes	AB	020675	ALLERGAN
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	202540	ENDO OPERATIONS
URSODIOL	URSODIOL	250MG	TABLET;ORAL	Prescription	No	AB	090801	GLENMARK PHARMS LTD
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
URSO FORTE	URSODIOL	500MG	TABLET;ORAL	Prescription	Yes	AB	020675	ALLERGAN
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	202540	ENDO OPERATIONS
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	090801	GLENMARK PHARMS LTD
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	213504	STRIDES PHARMA
URSODIOL	URSODIOL	500MG	TABLET;ORAL	Prescription	No	AB	211145	ZYDUS LIFESCIENCES

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