Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020137
Company: ROCHE
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEMADEX | TORSEMIDE | 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |
| DEMADEX | TORSEMIDE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INTRAVENOUS | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/23/1993 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/20/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/26/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/01/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/13/1998 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 09/09/1997 | SUPPL-8 | Efficacy-New Indication |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020136ap_s08_s09.pdf |
| 06/17/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/24/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1995 | SUPPL-2 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18735slr044and20137slr002LTR.pdf |
| 09/05/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |