APPLICATION
ANDA078015
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-27
LATEST ACTION
2021-09-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TAMSULOSIN HYDROCHLORIDEDiscontinued
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL
Approval history
2021-09-15Labeling · Supplement 14 · standardAP
2021-09-15Manufacturing (CMC) · Supplement 13 · unknownAP
2015-10-30Labeling · Supplement 7 · standardAP
2011-10-27Labeling · Supplement 5AP
2011-05-04Labeling · Supplement 3AP
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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