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FDA NDA · NDA021090

CYCLESSA

Sponsor: ASPEN GLOBAL INC

APPLICATION
NDA021090
TYPE
NDA
ORIGINAL APPROVAL
2000-12-20
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

CYCLESSA · ReferencePrescription
DESOGESTREL 0.1MG,0.125MG,0.15MG, ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 9 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 8 · standard — Label ↗AP
2015-09-10Manufacturing (CMC) · Supplement 7 · standardAP
2007-03-26Labeling · Supplement 4 · standard — Letter ↗AP
2004-02-24Labeling · Supplement 3 · standard — Letter ↗AP
2002-03-08Manufacturing (CMC) · Supplement 2 · standardAP
2001-06-27Manufacturing (CMC) · Supplement 1 · standardAP
2000-12-20Type 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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