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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021697
Company: CUMBERLAND

Products on NDA 021697

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021697

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

Labels for NDA 021697

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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