← FDA DRUG APPROVALS
FDA ANDA · ANDA076784
TRI-LO-SPRINTEC
norgestimate and ethinyl estradiol
Sponsor: BARR LABS INC
APPLICATION
ANDA076784
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-29
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRI LO SPRINTECPrescription
ETHINYL ESTRADIOL 0.025MG,0.025MG,0.025MG, NORGESTIMATE 0.18MG,0.215MG,0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 13 · standardAP
2022-01-28Labeling · Supplement 8 · standardAP
2016-04-19Labeling · Supplement 7 · standardAP
2012-11-26Labeling · Supplement 5 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.