APPLICATION
ANDA200383
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-07
LATEST ACTION
2023-10-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORGESTIMATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2023-10-03Labeling · Supplement 5 · standardAP
2022-04-29Labeling · Supplement 4 · standardAP
2022-02-02Labeling · Supplement 1 · standardAP
2022-02-02Labeling · Supplement 2 · standardAP
2015-04-07Not 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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