APPLICATION
NDA012885
TYPE
NDA
ORIGINAL APPROVAL
1962-01-09
LATEST ACTION
2003-11-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
WINSTROL · ReferenceDiscontinued
STANOZOLOL 2MG · TABLET · ORAL
Approval history
1994-04-07Manufacturing (CMC) · Supplement 34 · standardAP
1992-02-27Labeling · Supplement 36 · standardAP
1991-12-13Labeling · Supplement 35 · standardAP
1988-05-18Labeling · Supplement 33 · standardAP
1987-03-10Manufacturing (CMC) · Supplement 31 · standardAP
1987-02-24Labeling · Supplement 32 · standardAP
1986-05-07Labeling · Supplement 30 · standardAP
1984-05-14Efficacy · Supplement 25 · standardAP
1962-01-09Type 1 - New Molecular Entity · Original · 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.