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FDA ANDA · ANDA202791
LEVONORGESTREL AND ETHINYL ESTRADIOL
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA202791
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-09
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVONORGESTREL AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.09MG · TABLET · ORAL
Approval history
2022-04-29Labeling · Supplement 6 · standardAP
2022-03-18Labeling · Supplement 4 · standardAP
2017-08-09Labeling · Supplement 2 · standardAP
2016-06-16Labeling · Supplement 1 · standardAP
2015-04-09UNKNOWN · 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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