← FDA DRUG APPROVALS

FDA NDA · NDA206089

JATENZO

testosterone undecanoate

Sponsor: TOLMAR

APPLICATION
NDA206089
TYPE
NDA
ORIGINAL APPROVAL
2019-03-27
LATEST ACTION
2025-09-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

JATENZO · ReferencePrescription
TESTOSTERONE UNDECANOATE 237MG · CAPSULE · ORAL
JATENZO · ReferencePrescription
TESTOSTERONE UNDECANOATE 158MG · CAPSULE · ORAL
JATENZO · ReferencePrescription
TESTOSTERONE UNDECANOATE 198MG · CAPSULE · ORAL

Approval history

2025-09-12Labeling · Supplement 7 · standard — Label ↗AP
2025-07-11Labeling · Supplement 9 · standard — Label ↗AP
2019-03-27Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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