APPLICATION
ANDA040647
TYPE
ANDA
ORIGINAL APPROVAL
2009-10-05
LATEST ACTION
2025-07-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TESTOSTERONE ENANTHATEDiscontinued
TESTOSTERONE ENANTHATE 200MG/ML · INJECTABLE · INJECTION
Approval history
2025-07-11Labeling · Supplement 4 · standardAP
2020-09-23Labeling · Supplement 3 · standardAP
2015-09-18Labeling · Supplement 2 · 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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