APPLICATION
ANDA086417
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-07
LATEST ACTION
2025-07-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TESTOSTERONEDiscontinued
TESTOSTERONE 100MG/ML · INJECTABLE · INJECTION
Approval history
2025-07-11Labeling · Supplement 28 · standardAP
2016-10-27Labeling · Supplement 26 · standardAP
2016-10-25Labeling · Supplement 27 · standardAP
2015-05-11Labeling · Supplement 25 · standardAP
2014-06-19Labeling · Supplement 24 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 21AP
1999-02-02Manufacturing (CMC) · Supplement 19AP
1998-12-14Manufacturing (CMC) · Supplement 20AP
1998-10-08Manufacturing (CMC) · Supplement 16AP
1998-08-04Manufacturing (CMC) · Supplement 18AP
1998-05-07Manufacturing (CMC) · Supplement 17AP
1992-11-20Labeling · Supplement 15AP
1991-05-24Labeling · Supplement 14AP
1989-11-02Labeling · Supplement 13AP
1989-01-10Manufacturing (CMC) · Supplement 12AP
1986-05-02Manufacturing (CMC) · Supplement 5AP
1984-09-11Manufacturing (CMC) · Supplement 2AP
1983-07-07OriginalAP
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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