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FDA NDA · NDA022219

AVEED

testosterone undecanoate

Sponsor: ENDO OPERATIONS

APPLICATION
NDA022219
TYPE
NDA
ORIGINAL APPROVAL
2014-03-05
LATEST ACTION
2025-07-11
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AVEED · ReferencePrescription
TESTOSTERONE UNDECANOATE 750MG/3ML (250MG/ML) · INJECTABLE · INTRAMUSCULAR

Approval history

2025-07-11Labeling · Supplement 21 · standard — Label ↗AP
2024-10-08REMS · Supplement 20 — Letter ↗AP
2022-05-26REMS · Supplement 19 — Letter ↗AP
2021-08-16Labeling · Supplement 15 · standard — Letter ↗AP
2021-06-28REMS · Supplement 16 — Letter ↗AP
2020-06-30Labeling · Supplement 14 · standard — Letter ↗AP
2020-03-13Labeling · Supplement 13 · standard — Label ↗AP
2018-12-19REMS · Supplement 12 — Letter ↗AP
2018-09-01REMS · Supplement 11 — Letter ↗AP
2018-01-24Labeling · Supplement 10 · standard — Letter ↗AP
2016-12-09REMS · Supplement 8 — Letter ↗AP
2016-10-25Labeling · Supplement 9 · standard — Letter ↗AP
2015-05-11Labeling · Supplement 5 · standard — Review ↗AP
2015-03-03Labeling · Supplement 3 · standard — Label ↗AP
2014-06-19Labeling · Supplement 1 · unknown — Review ↗AP
2014-03-05Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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