Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022335
Company: CYCLOMEDICA
Company: CYCLOMEDICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TECHNEGAS KIT | TECHNETIUM TC-99M LABELED CARBON | N/A | AEROSOL;INHALATION | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/29/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022335Orig1s000lbl.pdf |