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FDA ANDA · ANDA078801

TAMSULOSIN HYDROCHLORIDE

Sponsor: SYNTHON BV

APPLICATION
ANDA078801
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-27
LATEST ACTION
2023-11-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TAMSULOSIN HYDROCHLORIDEPrescription
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL

Approval history

2023-11-02Labeling · Supplement 14 · standardAP
2011-10-17Labeling · Supplement 4AP
2010-04-27OriginalAP
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