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FDA NDA · NDA020497

FARESTON

toremifene citrate

Sponsor: KYOWA KIRIN

APPLICATION
NDA020497
TYPE
NDA
ORIGINAL APPROVAL
1997-05-29
LATEST ACTION
2024-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FARESTON · ReferenceDiscontinued
TOREMIFENE CITRATE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-12-13Labeling · Supplement 18 · standard — Label ↗AP
2017-05-12Labeling · Supplement 9 · standard — Label ↗AP
2011-03-21Labeling · Supplement 6 · standard — Label ↗AP
2000-07-10Manufacturing (CMC) · Supplement 3 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 2 · standardAP
1997-11-20Labeling · Supplement 1 · standardAP
1997-05-29Type 1 - New Molecular Entity · Original · standardAP
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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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