APPLICATION
ANDA207742
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-16
LATEST ACTION
2025-07-21
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TESTOSTERONE CYPIONATEPrescription
TESTOSTERONE CYPIONATE 200MG/ML · INJECTABLE · INJECTION
Approval history
2025-07-21Labeling · Supplement 2 · standardAP
2025-07-21Labeling · Supplement 16 · standardAP
2018-04-04Manufacturing (CMC) · Supplement 1 · unknownAP
2017-06-16UNKNOWN · Original · 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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