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FDA ANDA · ANDA201585
BLISOVI FE 1.5/30
norethindrone acetate and ethinyl estradiol
Sponsor: LUPIN
APPLICATION
ANDA201585
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-18
LATEST ACTION
2023-08-09
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BLISOVI FE 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-28
Approval history
2023-08-09Labeling · Supplement 20 · standardAP
2023-08-09Labeling · Supplement 19 · standardAP
2019-05-02Manufacturing (CMC) · Supplement 8AP
2019-05-02Labeling · Supplement 5 · standardAP
2015-11-18Not 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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