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FDA ANDA · ANDA091452
MARLISSA
levonorgestrel and ethinyl estradiol
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA091452
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-29
LATEST ACTION
2024-01-03
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MARLISSAPrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL-28
Approval history
2024-01-03Labeling · Supplement 10 · standardAP
2022-04-29Labeling · Supplement 9 · standardAP
2022-02-16Labeling · Supplement 8 · standardAP
2022-02-16Labeling · Supplement 6 · standardAP
2022-02-16Labeling · Supplement 7 · standardAP
2017-08-09Labeling · Supplement 5 · standardAP
2014-01-28Labeling · Supplement 3 · standardAP
2012-06-26Labeling · Supplement 1AP
2012-02-29OriginalAP
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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