← FDA DRUG APPROVALS
FDA ANDA · ANDA076381
JUNEL 21 DAY
norethindrone acetate and ethinyl estradiol
Sponsor: BARR
APPLICATION
ANDA076381
TYPE
ANDA
ORIGINAL APPROVAL
2003-05-30
LATEST ACTION
2023-09-25
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
JUNEL 1.5/30Prescription
ETHINYL ESTRADIOL 0.03MG, NORETHINDRONE ACETATE 1.5MG · TABLET · ORAL-21
Approval history
2023-09-25Labeling · Supplement 26 · standardAP
2023-09-25Labeling · Supplement 23 · standardAP
2021-08-18Labeling · Supplement 18 · standardAP
2004-10-20Labeling · Supplement 4AP
2003-05-30OriginalAP
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.
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.