Vaprisol, Vaprisol In 5% Dextrose In Plastic Container

NDA 21697, held by Apotex. Conivaptan Hydrochloride.

As of Nov 14, 2026, NDA 21697 (Vaprisol, Vaprisol In 5% Dextrose In Plastic Container), held by Apotex, was first approved by FDA on Dec 29, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 29, 2005
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 29, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Vaprisol20MG/4ML (5MG/ML) · injectable;intravenous	Conivaptan Hydrochloride	Discontinued
Vaprisol In 5% Dextrose In Plastic Container20MG/100ML (0.2MG/ML) · injectable;intravenous	Conivaptan Hydrochloride	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Oct 14, 2016	Supplement 5Labeling · Standard review	Approved	Letter Label
Feb 1, 2012	Supplement 3Labeling	Approved	Label Letter
May 27, 2010	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 8, 2008	Supplement 1Manufacturing	Approved	Label Letter
Dec 29, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21697
Drugs@FDA: Overview at FDA
Company: Apotex

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters