APPLICATION
ANDA091332
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-23
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEPrescription
ETHINYL ESTRADIOL 0.035MG, NORETHINDRONE 0.4MG · TABLET · ORAL
Approval history
2022-04-29Labeling · Supplement 10 · standardAP
2020-02-05Manufacturing (CMC) · Supplement 7 · unknownAP
2020-02-05Labeling · Supplement 1 · standardAP
2020-02-05Labeling · Supplement 4 · standardAP
2016-03-23OriginalAP
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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