APPLICATION
ANDA076334
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-09
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PREVIFEMDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 24 · standardAP
2022-02-03Labeling · Supplement 23 · standardAP
2016-02-24Labeling · Supplement 19 · standardAP
2016-02-24Labeling · Supplement 22 · standardAP
2014-04-30Manufacturing (CMC) · Supplement 20 · unknownAP
2013-01-03Labeling · Supplement 17 · standardAP
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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