Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210844
Company: PRAXAIR MEXICO
Company: PRAXAIR MEXICO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYGEN, USP | OXYGEN | 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 |
|---|---|---|---|---|---|---|---|
| 09/03/2017 | ORIG-1 | Approval | UNKNOWN |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/NDA210844-NADA141486-DeemedGranted-signed.pdf |