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FDA ANDA · ANDA091408
KURVELO
levonorgestrel and ethinyl estradiol
Sponsor: LUPIN LTD
APPLICATION
ANDA091408
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-17
LATEST ACTION
2023-02-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
KURVELOPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28
Approval history
2023-02-03Labeling · Supplement 15 · standardAP
2022-04-29Labeling · Supplement 14 · standardAP
2022-03-01Labeling · Supplement 13 · standardAP
2020-03-02Manufacturing (CMC) · Supplement 10AP
2020-03-02Labeling · Supplement 9 · standardAP
2020-03-02Labeling · Supplement 7 · standardAP
2017-08-09Labeling · Supplement 5 · standardAP
2014-01-28Labeling · Supplement 3 · standardAP
2012-10-17OriginalAP
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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