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FDA ANDA · ANDA201584
BLISOVI FE 1/20
norethindrone acetate and ethinyl estradiol
Sponsor: LUPIN
APPLICATION
ANDA201584
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-18
LATEST ACTION
2020-08-31
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BLISOVI FE 1/20Prescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-28
Approval history
2020-08-31Labeling · Supplement 11 · standardAP
2020-08-31Manufacturing (CMC) · Supplement 16AP
2018-09-26Manufacturing (CMC) · Supplement 6 · standardAP
2018-09-26Labeling · Supplement 4 · 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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