APPLICATION
ANDA202132
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-09
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORGESTIMATE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 6 · standardAP
2018-12-21Labeling · Supplement 4 · standardAP
2018-12-21Labeling · Supplement 3 · standardAP
2015-09-09Not 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.