Carbon Dioxide, Usp (carbon dioxide, usp)

Where it stands

Carbon Dioxide, USP (carbon dioxide, USP) from AGL Welding Supply Co Inc dba AGL Gas Technologies is recorded as FDA-approved in the US. The approval is under NDA222000, with an approval date of 2026-09-22. The records list the dosage form as gas and cite an official source.

The records do not give an indication or a therapeutic area, so the approved use cannot be described from this data. No CHMP opinion is recorded. That is expected for a US-only entry, since a CHMP opinion belongs to the EU centralised procedure.

The same substance has a prior US approval in the records: Carbon Dioxide, USP, Roberts Oxygen Co Inc, NDA221021, approved 2025-10-25. The AGL product is therefore not the first US approval for this substance. It sits alongside at least one earlier approval from a different sponsor under a separate NDA.

Regulatory pathway and designations

The records show a US FDA approval under a New Drug Application number (NDA222000). They do not say which NDA type or review route was used, nor give review timelines, a PDUFA date or advisory committee activity.

No designations are recorded. That means no orphan, fast track, breakthrough, priority review or similar status appears in the data. It does not prove none exists, only that none is captured here.

In general, medical gases are regulated as drugs in the US, and separate sponsors often hold separate applications for the same substance. That fits the two distinct NDA numbers here. The records do not show whether either application relied on the other or on any other data package.

Safety and pharmacovigilance

The records contain no safety information. They list no labelled warnings, adverse event data, risk management measures, postmarketing requirements or safety communications for this product.

Any assessment of benefit-risk, contraindications or handling precautions would need the FDA-approved labelling and the associated review documents, which are not part of this dataset. Routine postmarketing safety reporting applies to approved drugs in general, but nothing here describes product-specific commitments.

What to watch

The first step is to retrieve the approved labelling for NDA222000. It will confirm the indication, the strengths or presentations and the approval conditions that are blank in the records. Comparing it with the Roberts Oxygen label under NDA221021 would show whether the two products have the same labelled use.

It is also worth tracking whether further sponsors receive approvals for carbon dioxide, USP, since the records already show more than one. Any later labelling changes or safety communications would also need monitoring through FDA sources. The records give no basis for forecasting commercial or regulatory developments.