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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075517
Company: EPIC PHARMA

Products on ANDA 075517

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075517

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2000	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75517ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75517_Ursodiol.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/06/2015	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/30/2007	SUPPL-6	Labeling		Label is not available on this site.
04/11/2005	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075517

URSODIOL

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACTIGALL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	Yes	AB	019594	TEVA BRANDED PHARM
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	210707	ABHAI LLC
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	211301	AMNEAL PHARMS CO
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	214849	AUROBINDO PHARMA LTD
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	213555	CHARTWELL RX
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	075517	EPIC PHARMA
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	212452	EYWA PHARMA
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	079082	LANNETT CO INC
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	213200	RISING
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	214329	RK PHARMA
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	210344	STRIDES PHARMA
URSODIOL	URSODIOL	300MG	CAPSULE;ORAL	Prescription	No	AB	214295	ZYDUS LIFESCIENCES

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