APPLICATION
ANDA076335
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-26
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRI-PREVIFEMDiscontinued
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 21 · standardAP
2022-02-03Labeling · Supplement 20 · standardAP
2016-02-24Manufacturing (CMC) · Supplement 16 · unknownAP
2016-02-24Labeling · Supplement 19 · standardAP
2014-12-19Labeling · Supplement 17 · standardAP
2013-01-03Labeling · Supplement 14 · 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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