Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017788
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RIMSO-50 | DIMETHYL SULFOXIDE | 50% | SOLUTION;INTRAVESICAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/04/1978 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/27/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/2008 | SUPPL-19 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/04/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1989 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/12/1988 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1980 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/29/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |