APPLICATION
ANDA086030
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-30
LATEST ACTION
2025-07-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TESTOSTERONE CYPIONATEDiscontinued
TESTOSTERONE CYPIONATE 200MG/ML · INJECTABLE · INJECTION
Approval history
2025-07-11Labeling · Supplement 51 · standardAP
2016-10-25Labeling · Supplement 50 · standardAP
2015-07-22Labeling · Supplement 49 · standardAP
2015-05-11Labeling · Supplement 48 · standardAP
2014-06-19Labeling · Supplement 46 · standardAP
2004-06-16Labeling · Supplement 24AP
1999-02-19Manufacturing (CMC) · Supplement 22AP
1999-02-02Manufacturing (CMC) · Supplement 21AP
1998-04-28Manufacturing (CMC) · Supplement 20AP
1996-12-04Manufacturing (CMC) · Supplement 19AP
1993-04-20Labeling · Supplement 18AP
1992-04-07Manufacturing (CMC) · Supplement 16AP
1992-04-07Manufacturing (CMC) · Supplement 14AP
1991-07-16Labeling · Supplement 17AP
1990-02-16Labeling · Supplement 15AP
1988-08-02Manufacturing (CMC) · Supplement 12AP
1988-08-02Manufacturing (CMC) · Supplement 11AP
1986-06-09Manufacturing (CMC) · Supplement 9AP
1985-05-29Manufacturing (CMC) · Supplement 5AP
1985-05-29Manufacturing (CMC) · Supplement 6AP
1983-11-09Manufacturing (CMC) · Supplement 4AP
1982-11-15Manufacturing (CMC) · Supplement 3AP
1981-07-30OriginalAP
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.
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