APPLICATION
ANDA080188
TYPE
ANDA
ORIGINAL APPROVAL
1974-05-02
LATEST ACTION
2016-10-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TESTOSTERONE PROPIONATEDiscontinued
TESTOSTERONE PROPIONATE 100MG/ML · INJECTABLE · INJECTION
TESTOSTERONE PROPIONATEDiscontinued
TESTOSTERONE PROPIONATE 25MG/ML · INJECTABLE · INJECTION
TESTOSTERONE PROPIONATEDiscontinued
TESTOSTERONE PROPIONATE 50MG/ML · INJECTABLE · INJECTION
Approval history
2016-10-27Labeling · Supplement 121 · standardAP
2016-10-25Labeling · Supplement 122 · standardAP
2015-05-11Labeling · Supplement 120 · standardAP
2014-06-19Labeling · Supplement 119 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 117AP
1999-02-02Manufacturing (CMC) · Supplement 116AP
1997-12-08Manufacturing (CMC) · Supplement 115AP
1997-05-05Manufacturing (CMC) · Supplement 114AP
1996-12-04Manufacturing (CMC) · Supplement 113AP
1993-08-03Labeling · Supplement 112AP
1991-04-15Labeling · Supplement 111AP
1991-02-01Labeling · Supplement 110AP
1990-03-22Labeling · Supplement 109AP
1988-10-05Manufacturing (CMC) · Supplement 107AP
1988-10-05Manufacturing (CMC) · Supplement 108AP
1988-10-05Manufacturing (CMC) · Supplement 106AP
1988-02-17Labeling · Supplement 105AP
1986-06-09Manufacturing (CMC) · Supplement 103AP
1984-07-16Manufacturing (CMC) · Supplement 102AP
1974-05-02OriginalAP
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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