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FDA ANDA · ANDA090060

FINASTERIDE

Sponsor: HETERO LABS LTD III

APPLICATION
ANDA090060
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-01
LATEST ACTION
2022-05-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FINASTERIDEPrescription
FINASTERIDE 1MG · TABLET · ORAL

Approval history

2022-05-05Labeling · Supplement 4 · standardAP
2016-11-22Manufacturing (CMC) · Supplement 2 · unknownAP
2014-12-14Labeling · Supplement 1 · standardAP
2013-07-01OriginalAP
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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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