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FDA ANDA · ANDA091674
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
levonorgestrel and ethinyl estradiol
Sponsor: LUPIN LTD
APPLICATION
ANDA091674
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-26
LATEST ACTION
2023-03-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG,0.1MG, LEVONORGESTREL 0.01MG,N/A · TABLET · ORAL
Approval history
2023-03-24Labeling · Supplement 12 · standardAP
2023-03-24Labeling · Supplement 10 · standardAP
2023-03-24Labeling · Supplement 13 · standardAP
2013-02-27Labeling · Supplement 1 · standardAP
2013-01-31Labeling · Supplement 2 · standardAP
2011-10-26Not 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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