APPLICATION
ANDA204645
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-20
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TAMSULOSIN HYDROCHLORIDEPrescription
TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL
Approval history
2023-06-07Labeling · Supplement 16 · standardAP
2019-09-23Labeling · Supplement 9 · standardAP
2017-06-26Manufacturing (CMC) · Supplement 1 · unknownAP
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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