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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078801
Company: SYNTHON BV

Products on ANDA 078801

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 078801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/27/2010	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
11/02/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
10/17/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078801

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
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	214730	ASCENT PHARMS INC
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	219767	RISING
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078015	SANDOZ
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078938	SCIEGEN PHARMS
TAMSULOSIN HYDROCHLORIDE	TAMSULOSIN HYDROCHLORIDE	0.4MG	CAPSULE;ORAL	Prescription	No	AB	078801	SYNTHON BV
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	078225	ZYDUS PHARMS USA INC

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