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FDA NDA · NDA018405

AYGESTIN

Sponsor: DURAMED RES

APPLICATION
NDA018405
TYPE
NDA
ORIGINAL APPROVAL
1982-04-21
LATEST ACTION
2007-07-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AYGESTIN · ReferenceDiscontinued
NORETHINDRONE ACETATE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2007-07-05Manufacturing (CMC) · Supplement 23 · standard — Letter ↗AP
2002-11-06Manufacturing (CMC) · Supplement 21 · standardAP
2000-04-12Labeling · Supplement 16 · standardAP
1997-11-11Manufacturing (CMC) · Supplement 15 · standardAP
1991-03-27Labeling · Supplement 12AP
1990-09-20Manufacturing (CMC) · Supplement 13 · standardAP
1988-12-20Manufacturing (CMC) · Supplement 11 · standardAP
1987-12-28Labeling · Supplement 10AP
1987-08-26Manufacturing (CMC) · Supplement 8 · standardAP
1986-02-19Labeling · Supplement 7AP
1983-11-08Labeling · Supplement 3AP
1982-04-21Type 5 - New Formulation or New Manufacturer · 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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