APPLICATION
ANDA205630
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-27
LATEST ACTION
2025-03-07
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORGESTIMATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG · TABLET · ORAL-28
Approval history
2025-03-07Labeling · Supplement 12 · standardAP
2022-04-29Labeling · Supplement 8 · standardAP
2019-02-14Labeling · Supplement 3 · standardAP
2019-02-14Manufacturing (CMC) · Supplement 4 · unknownAP
2016-10-27UNKNOWN · Original · 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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