← FDA DRUG APPROVALS

FDA NDA · NDA208088

TLANDO

testosterone undecanoate

Sponsor: VERITY

APPLICATION
NDA208088
TYPE
NDA
ORIGINAL APPROVAL
2022-03-28
LATEST ACTION
2025-07-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TLANDO · ReferencePrescription
TESTOSTERONE UNDECANOATE 112.5MG · CAPSULE · ORAL

Approval history

2025-07-11Labeling · Supplement 2 · standardLabelAP
2022-03-28Type 3 - New Dosage Form · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →