APPLICATION
ANDA090387
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-15
LATEST ACTION
2025-07-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TESTOSTERONE CYPIONATEPrescription
TESTOSTERONE CYPIONATE 100MG/ML · INJECTABLE · INJECTION
TESTOSTERONE CYPIONATEPrescription
TESTOSTERONE CYPIONATE 200MG/ML · INJECTABLE · INJECTION
Approval history
2025-07-14Labeling · Supplement 9 · standardAP
2014-06-19Labeling · Supplement 5 · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.