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FDA ANDA · ANDA084949

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Sponsor: MONARCH PHARMS

APPLICATION
ANDA084949
TYPE
ANDA
ORIGINAL APPROVAL
1977-09-28
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

MENESTDiscontinued
ESTROGENS, ESTERIFIED 2.5MG · TABLET · ORAL

Approval history

2024-02-15Labeling · Supplement 24 · standardAP
2019-04-08Labeling · Supplement 23 · standardAP
2004-12-01Labeling · Supplement 18AP
2000-04-28Manufacturing (CMC) · Supplement 15AP
1992-05-01Manufacturing (CMC) · Supplement 9AP
1992-05-01Labeling · Supplement 11AP
1990-05-10Labeling · Supplement 10AP
1982-06-21Manufacturing (CMC) · Supplement 3AP
1977-09-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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