Application 021697

Type
NDA
Sponsor
CUMBERLAND PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001VAPRISOLCONIVAPTAN HYDROCHLORIDEINJECTABLE;INTRAVENOUS20MG/4ML (5MG/ML)NoNo
002VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINERCONIVAPTAN HYDROCHLORIDEINJECTABLE;INTRAVENOUS20MG/100ML (0.2MG/ML)YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0469-1602Vaprisolconivaptan hydrochlorideAstellas Pharma US, Inc.NDACurrent
66220-160VAPRISOL DEXTROSE IN PLASTIC CONTAINERconivaptan hydrochlorideCumberland Pharmaceuticals Inc.NDACurrent

Documents

DocumentSubmission typeDate
45620SUPPL2016-10-17
45549SUPPL2016-10-17
16218SUPPL2012-02-06
6007SUPPL2012-02-03
16217SUPPL2010-06-03
6006SUPPL2010-06-02
37474SUPPL2008-11-07
6005SUPPL2008-10-14
42274ORIG2006-03-24
28397ORIG2006-01-06
37473ORIG2005-12-30