← FDA DRUG APPROVALS

FDA NDA · NDA211635

VALTOCO

diazepam

Sponsor: NEURELIS INC

APPLICATION
NDA211635
TYPE
NDA
ORIGINAL APPROVAL
2020-01-10
LATEST ACTION
2025-06-14
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

VALTOCO · ReferencePrescription
DIAZEPAM 7.5MG/SPRAY · SPRAY · NASAL
VALTOCO · ReferencePrescription
DIAZEPAM 10MG/SPRAY · SPRAY · NASAL
VALTOCO · ReferencePrescription
DIAZEPAM 5MG/SPRAY · SPRAY · NASAL

Approval history

2025-06-14Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2025-04-15Efficacy · Supplement 10 · standard — Letter ↗AP
2023-01-13Labeling · Supplement 8 · standard — Letter ↗AP
2022-02-04Labeling · Supplement 7 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 3 · standard — Letter ↗AP
2020-01-10Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →