← FDA DRUG APPROVALS

FDA NDA · NDA205488

NATESTO NASAL GEL

testosterone

Sponsor: ACERUS

APPLICATION
NDA205488
TYPE
NDA
ORIGINAL APPROVAL
2014-05-28
LATEST ACTION
2025-07-11
ROUTE
NASAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Prescription

Products

NATESTO · ReferencePrescription
TESTOSTERONE 5.5MG/0.122GM ACTUATION · GEL, METERED · NASAL

Approval history

2025-07-11Labeling · Supplement 5 · standard — Label ↗AP
2016-10-25Labeling · Supplement 2 · standard — Letter ↗AP
2015-05-11Labeling · Supplement 1 · standard — Label ↗AP
2014-05-28Type 5 - New Formulation or New Manufacturer · 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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