APPLICATION
ANDA076225
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-21
LATEST ACTION
2025-10-10
ROUTE
ORAL, ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ERRINPrescription
NORETHINDRONE 0.35MG · TABLET · ORAL-28
Approval history
2025-10-10Labeling · Supplement 14 · standardAP
2015-04-02Labeling · Supplement 11 · standardAP
2011-06-10Labeling · Supplement 6AP
2002-10-21OriginalAP
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.