Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202433
Company: AUROBINDO PHARMA LTD

Products on ANDA 202433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2013	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
09/09/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/11/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/11/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/11/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202433

TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL; 0.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLOMAX	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	Yes	AB	020579	SANOFI
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	207405	ALKEM LABS LTD
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	202433	AUROBINDO PHARMA LTD
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	211885	CHARTWELL RX
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	090377	IMPAX LABS
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	204645	MACLEODS PHARMS LTD
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078015	SANDOZ
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	090931	SUN PHARM INDS LTD
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078801	SYNTHON PHARMS
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	077630	TEVA PHARMS
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078938	WOCKHARDT
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078225	ZYDUS PHARMS USA INC