APPLICATION
ANDA202660
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-20
LATEST ACTION
2023-04-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DUTASTERIDEPrescription
DUTASTERIDE 0.5MG · CAPSULE · ORAL
Approval history
2023-04-26Labeling · Supplement 3 · standardAP
2015-11-20UNKNOWN · OriginalAP
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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