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FDA ANDA · ANDA090793
TRI-ESTARYLLA
norgestimate and ethinyl estradiol
Sponsor: XIROMED
APPLICATION
ANDA090793
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-30
LATEST ACTION
2024-02-01
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRI-ESTARYLLAPrescription
ETHINYL ESTRADIOL 0.035MG,0.035MG,0.035MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2024-02-01Labeling · Supplement 11 · standardAP
2022-04-29Labeling · Supplement 10 · standardAP
2022-02-03Labeling · Supplement 6 · standardAP
2015-08-25Labeling · Supplement 3 · standardAP
2015-08-25Labeling · Supplement 4 · standardAP
2013-01-30OriginalAP
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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