Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021697
Company: CUMBERLAND
Company: CUMBERLAND
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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/29/2005 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021697lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021697s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021697s000_VaprisolTOC.cfm |
Supplements
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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021697s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021697Orig1s005ltr.pdf | |
02/01/2012 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021697s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021697s003ltr.pdf | |
05/27/2010 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021697s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021697s002ltr.pdf | |
10/08/2008 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021697s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021697s001ltr.pdf |
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 |