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FDA ANDA · ANDA091467
DAYSEE
levonorgestrel and ethinyl estradiol
Sponsor: LUPIN LTD
APPLICATION
ANDA091467
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-10
LATEST ACTION
2026-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DAYSEEPrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL
Approval history
2026-01-28Manufacturing (CMC) · Supplement 16 · unknownAP
2013-04-10Not 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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