APPLICATION
ANDA078225
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-27
LATEST ACTION
2019-09-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TAMSULOSIN HYDROCHLORIDEPrescription
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL
Approval history
2019-09-09Labeling · Supplement 14 · standardAP
2015-04-22Labeling · Supplement 6 · standardAP
2015-04-22Labeling · Supplement 5 · standardAP
2011-08-29Labeling · Supplement 4AP
2010-10-02Manufacturing (CMC) · Supplement 1AP
2010-04-27OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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