Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019922
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORLOPAM | FENOLDOPAM MESYLATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/02/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019922s019lbl.pdf | |
| 12/17/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019922s016lbl.pdf | |
| 04/01/2004 | SUPPL-5 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19922se5-005_colopam_lbl.pdf |