Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021697
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
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

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