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FDA ANDA · ANDA200541
TRI-LO-MARZIA
norgestimate and ethinyl estradiol
Sponsor: LUPIN PHARMS
APPLICATION
ANDA200541
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-25
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NORGESTIMATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 12 · standardAP
2019-01-28Labeling · Supplement 5 · standardAP
2019-01-28Manufacturing (CMC) · Supplement 8 · unknownAP
2012-09-26Labeling · Supplement 1 · standardAP
2012-06-25Not 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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