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FDA ANDA · ANDA077077

GILDESS FE 1/20

Sponsor: PH HEALTH

APPLICATION
ANDA077077
TYPE
ANDA
ORIGINAL APPROVAL
2005-05-20
LATEST ACTION
2016-09-29
ROUTE
ORAL-28, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GILDESS FE 1/20Discontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-28
GILDESS 1/20Discontinued
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-21

Approval history

2016-09-29Manufacturing (CMC) · Supplement 11 · unknownAP
2014-11-28Labeling · Supplement 7 · standardAP
2009-03-27Labeling · Supplement 2AP
2005-05-20OriginalAP
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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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