Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 220634
Company: GENERAL DISTRIBUTING COMPANY

Products on NDA 220634

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBON DIOXIDE, USP	CARBON DIOXIDE		GAS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 220634

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2025	ORIG-1	Approval		UNKNOWN	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/220634Orig1s000MGLtr.pdf