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FDA ANDA · ANDA076105

TRI-LEGEST FE 28 DAY

norethindrone acetate and ethinyl estradiol

Sponsor: BARR

APPLICATION
ANDA076105
TYPE
ANDA
ORIGINAL APPROVAL
2007-10-26
LATEST ACTION
2025-06-18
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRI-LEGEST FEPrescription
ETHINYL ESTRADIOL 0.02MG,0.03MG,0.035MG, NORETHINDRONE ACETATE 1MG,1MG,1MG · TABLET · ORAL-28

Approval history

2025-06-18Labeling · Supplement 20 · standardAP
2021-10-15Labeling · Supplement 13 · standardAP
2021-08-06Labeling · Supplement 8 · standardAP
2021-08-06Labeling · Supplement 9 · standardAP
2007-10-26OriginalAP
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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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