APPLICATION
ANDA204376
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-07
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DUTASTERIDEPrescription
DUTASTERIDE 0.5MG · CAPSULE · ORAL
Approval history
2024-11-14Labeling · Supplement 1 · standardAP
2017-04-07UNKNOWN · 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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