Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203118
Company: AMNEAL PHARMS

Products on ANDA 203118

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203118

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/22/2020	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203118

DUTASTERIDE

CAPSULE;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AVODART	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	Yes	AB	021319	WAYLIS THERAP
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	206373	ACELLA
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	204376	ADAPTIS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	203118	AMNEAL PHARMS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	206574	ASCENT PHARMS INC
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	202660	AUROBINDO PHARMA LTD
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	090095	BARR
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	200899	CHARTWELL
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	209909	HUMANWELL PURACAP
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	204262	STRIDES SOFTGELS
DUTASTERIDE	DUTASTERIDE	0.5MG	CAPSULE;ORAL	Prescription	No	AB	204373	ZYDUS LIFESCIENCES