Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021697
Company: CUMBERLAND PHARMS
Company: CUMBERLAND PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VAPRISOL | CONIVAPTAN HYDROCHLORIDE | 20MG/4ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER | CONIVAPTAN HYDROCHLORIDE | 20MG/100ML (0.2MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/14/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021697s005lbl.pdf | |
| 02/01/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021697s003lbl.pdf | |
| 05/27/2010 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021697s002lbl.pdf | |
| 10/08/2008 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021697s001lbl.pdf | |
| 10/08/2008 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021697s001lbl.pdf | |
| 12/29/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021697lbl.pdf |