APPLICATION
ANDA202509
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-26
LATEST ACTION
2023-04-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDEPrescription
DUTASTERIDE 0.5MG, TAMSULOSIN HYDROCHLORIDE 0.4MG · CAPSULE · ORAL
Approval history
2023-04-26Labeling · Supplement 16 · standardAP
2020-10-23Labeling · Supplement 11 · standardAP
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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