APPLICATION
ANDA201896
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2026-01-07
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORGESTIMATE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG · TABLET · ORAL-28
Approval history
2026-01-07Labeling · Supplement 7 · standardAP
2022-04-29Labeling · Supplement 5 · standardAP
2018-11-09Labeling · Supplement 2 · standardAP
2018-11-09Labeling · Supplement 1 · standardAP
2016-01-27Not Applicable · OriginalAP
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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