← FDA DRUG APPROVALS
FDA ANDA · ANDA076380
JUNEL 21 DAY
norethindrone acetate and ethinyl estradiol
Sponsor: BARR LABS
APPLICATION
ANDA076380
TYPE
ANDA
ORIGINAL APPROVAL
2003-05-30
LATEST ACTION
2023-09-25
ROUTE
ORAL, ORAL-21
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
JUNEL 1/20Prescription
ETHINYL ESTRADIOL 0.02MG, NORETHINDRONE ACETATE 1MG · TABLET · ORAL-21
Approval history
2023-09-25Labeling · Supplement 23 · standardAP
2023-09-25Labeling · Supplement 26 · standardAP
2021-08-18Labeling · Supplement 17 · 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.