Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220173
Company: STIRA
Company: STIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIMETHYL SULFOXIDE | DIMETHYL SULFOXIDE | 50% | SOLUTION;INTRAVESICAL | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 07/07/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DIMETHYL SULFOXIDE
SOLUTION;INTRAVESICAL; 50%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DIMETHYL SULFOXIDE | DIMETHYL SULFOXIDE | 50% | SOLUTION;INTRAVESICAL | Prescription | No | AT | 220173 | STIRA |
| RIMSO-50 | DIMETHYL SULFOXIDE | 50% | SOLUTION;INTRAVESICAL | Prescription | Yes | AT | 017788 | MYLAN INSTITUTIONAL |