← FDA DRUG APPROVALS

FDA NDA · NDA022335

TECHNEGAS

kit for the preparation of technetium tc 99m-labeled carbon inhalation aerosol

Sponsor: CYCLOMEDICA

APPLICATION
NDA022335
TYPE
NDA
ORIGINAL APPROVAL
2023-09-29
LATEST ACTION
2023-09-29
ROUTE
INHALATION
DOSAGE FORM
AEROSOL
MARKETING STATUS
Prescription

Products

TECHNEGAS KIT · ReferencePrescription
TECHNETIUM TC-99M LABELED CARBON N/A · AEROSOL · INHALATION

Approval history

2023-09-29Type 3 - New Dosage Form · Original · standard — Review ↗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 →