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FDA ANDA · ANDA091398

BLISOVI 24 FE

norethindrone acetate and ethinyl estradiol

Sponsor: LUPIN

APPLICATION
ANDA091398
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-28
LATEST ACTION
2025-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BLISOVI 24 FEPrescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL

Approval history

2025-06-18Labeling · Supplement 23 · standardAP
2025-06-18Labeling · Supplement 22 · standardAP
2022-04-29Labeling · Supplement 20 · standardAP
2019-11-15Manufacturing (CMC) · Supplement 14 · unknownAP
2019-05-01Labeling · Supplement 5 · standardAP
2019-05-01Labeling · Supplement 1 · standardAP
2019-05-01Manufacturing (CMC) · Supplement 9AP
2015-10-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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