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FDA NDA · NDA021443

ENJUVIA

Sponsor: ASPEN

APPLICATION
NDA021443
TYPE
NDA
ORIGINAL APPROVAL
2004-05-10
LATEST ACTION
2026-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ENJUVIADiscontinued
ESTROGENS, CONJUGATED SYNTHETIC B 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ENJUVIADiscontinued
ESTROGENS, CONJUGATED SYNTHETIC B 0.45MG · TABLET · ORAL
ENJUVIADiscontinued
ESTROGENS, CONJUGATED SYNTHETIC B 0.9MG · TABLET · ORAL
ENJUVIADiscontinued
ESTROGENS, CONJUGATED SYNTHETIC B 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ENJUVIADiscontinued
ESTROGENS, CONJUGATED SYNTHETIC B 0.3MG · TABLET · ORAL

Approval history

2026-02-12Labeling · Supplement 14 · standard — Label ↗AP
2024-02-15Labeling · Supplement 13 · standard — Letter ↗AP
2020-11-30Labeling · Supplement 11 · standard — Label ↗AP
2020-11-30Labeling · Supplement 12 · standard — Label ↗AP
2017-11-01Labeling · Supplement 10 · standard — Label ↗AP
2015-06-30Labeling · Supplement 9 · standard — Letter ↗AP
2007-04-27Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2007-04-23Efficacy · Supplement 4 · unknown — Label ↗AP
2004-05-10Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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