Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216307
Company: GENERAL AIR SERVICE & SUPPLY COMPANY
Company: GENERAL AIR SERVICE & SUPPLY COMPANY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HELIUM, USP | HELIUM | N/A | GAS;INHALATION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/26/2021 | ORIG-1 | Approval | UNKNOWN |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/216307Orig1s000MGLtr.pdf |