Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213555
Company: CHARTWELL RX

Products on ANDA 213555

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 213555

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2020	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
08/17/2020	SUPPL-1			Label is not available on this site.

Therapeutic Equivalents for ANDA 213555

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	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	HIBROW HLTHCARE
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