APPLICATION
ANDA086029
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-23
LATEST ACTION
2016-10-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TESTOSTERONE CYPIONATEDiscontinued
TESTOSTERONE CYPIONATE 100MG/ML · INJECTABLE · INJECTION
Approval history
2016-10-25Labeling · Supplement 89 · standardAP
2015-07-20Labeling · Supplement 88 · standardAP
2015-05-11Labeling · Supplement 87 · standardAP
2014-06-19Labeling · Supplement 86 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 84AP
1999-02-02Manufacturing (CMC) · Supplement 83AP
1998-04-30Manufacturing (CMC) · Supplement 82AP
1996-12-04Manufacturing (CMC) · Supplement 81AP
1993-04-20Labeling · Supplement 80AP
1991-07-16Labeling · Supplement 79AP
1990-02-16Labeling · Supplement 78AP
1988-12-23Manufacturing (CMC) · Supplement 76AP
1988-12-23Manufacturing (CMC) · Supplement 77AP
1988-12-23Manufacturing (CMC) · Supplement 75AP
1986-06-09Manufacturing (CMC) · Supplement 72AP
1982-11-22Manufacturing (CMC) · Supplement 68AP
1982-11-22Manufacturing (CMC) · Supplement 70AP
1978-06-23OriginalAP
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.