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FDA NDA · NDA020683

ALESSE

Sponsor: CADENCE HEALTH

APPLICATION
NDA020683
TYPE
NDA
ORIGINAL APPROVAL
1997-03-27
LATEST ACTION
2024-07-16
ROUTE
ORAL-21, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ALESSE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-21
ALESSE · ReferenceDiscontinued
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL-28

Approval history

2024-07-16Labeling · Supplement 14 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 16 · standard — Letter ↗AP
2018-03-20Labeling · Supplement 12 · standard — Label ↗AP
2017-08-09Labeling · Supplement 11 · standard — Label ↗AP
2008-01-31Labeling · Supplement 7 · standard — Label ↗AP
2008-01-31Labeling · Supplement 6 · standard — Letter ↗AP
2008-01-31Labeling · Supplement 4 · standard — Label ↗AP
2002-03-06Manufacturing (CMC) · Supplement 5 · standardAP
1998-02-12Manufacturing (CMC) · Supplement 1 · standardAP
1997-03-27Type 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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