APPLICATION
ANDA040530
TYPE
ANDA
ORIGINAL APPROVAL
2005-01-31
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 28 · standardAP
2025-07-11Labeling · Supplement 34 · standardAP
2021-07-13Labeling · Supplement 26 · standardAP
2017-01-25Labeling · Supplement 11 · standardAP
2016-10-25Labeling · Supplement 14 · standardAP
2015-05-11Labeling · Supplement 10 · standardAP
2014-06-19Labeling · Supplement 8 · standardAP
2005-01-31OriginalAP
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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