APPLICATION
ANDA080911
TYPE
ANDA
ORIGINAL APPROVAL
1972-07-13
LATEST ACTION
2025-07-11
ROUTE
SUBCUTANEOUS, IMPLANTATION
DOSAGE FORM
PELLET
MARKETING STATUS
Prescription
Products
TESTOPELPrescription
TESTOSTERONE 75MG · PELLET · IMPLANTATION
Approval history
2025-07-11Labeling · Supplement 29 · standardAP
2016-10-25Labeling · Supplement 23 · standardAP
2016-10-17Labeling · Supplement 22 · standardAP
2016-08-01Labeling · Supplement 20 · standardAP
2015-05-11Labeling · Supplement 19 · standardAP
2014-11-17Labeling · Supplement 17 · standardAP
1996-04-08Manufacturing (CMC) · Supplement 13AP
1995-02-24Manufacturing (CMC) · Supplement 10AP
1992-12-21Labeling · Supplement 9AP
1992-05-08Labeling · Supplement 8AP
1986-09-10Manufacturing (CMC) · Supplement 5AP
1986-09-10Manufacturing (CMC) · Supplement 6AP
1982-08-03Manufacturing (CMC) · Supplement 4AP
1972-07-13OriginalAP
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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