APPLICATION
ANDA090479
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-09
LATEST ACTION
2022-04-29
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
NORGESTIMATE; ETHINYL ESTRADIOLPrescription
NORGESTIMATE 0.25MG, ETHINYL ESTRADIOL 0.025MG · TABLET · ORAL
NORGESTIMATE AND ETHINYL ESTRADIOLDiscontinued
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
NORGESTIMATE; ETHINYL ESTRADIOLPrescription
NORGESTIMATE 0.215MG, ETHINYL ESTRADIOL 0.025MG · TABLET · ORAL
Approval history
2022-04-29Labeling · Supplement 2 · standardAP
2022-02-03Labeling · Supplement 1 · standardAP
2011-03-09OriginalAP
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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