Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077155
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENOLDOPAM MESYLATE | FENOLDOPAM MESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 02/15/2005 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/077155Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/11/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2023 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/28/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |