Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208069
Company: STRATA MEDICAL INNOVATIONS
Company: STRATA MEDICAL INNOVATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NITROUS OXIDE, USP | NITROUS OXIDE | 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 |
---|---|---|---|---|---|---|---|
11/25/2014 | ORIG-1 | Approval | UNKNOWN |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/208069MGLtr.pdf |