APPLICATION
ANDA091244
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-01
LATEST ACTION
2025-07-11
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TESTOSTERONE CYPIONATEPrescription
TESTOSTERONE CYPIONATE 200MG/ML · INJECTABLE · INJECTION
Approval history
2025-07-11Labeling · Supplement 23 · standardAP
2025-07-09Labeling · Supplement 12 · standardAP
2025-07-09Labeling · Supplement 13 · standardAP
2017-03-27Labeling · Supplement 7 · standardAP
2016-07-26Supplement · Supplement 2AP
2015-07-22Labeling · Supplement 6 · standardAP
2015-05-11Labeling · Supplement 5 · standardAP
2014-06-19Labeling · Supplement 4 · 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.
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