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Application 021892

Type
NDA
Sponsor
SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSMOPREPSODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATETABLET;ORAL0.398GM;1.102GMYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-701OsmoPrepSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUSSalix Pharmaceuticals, Inc.NDACurrent
65649-701OsmoPrepSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUSSalix Pharmaceuticals, Inc.NDACurrent
65649-701OsmoPrepSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUSSalix Pharmaceuticals, Inc.NDACurrent
65649-701OsmoPrepSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, SODIUM PHOSPHATE, DIBASIC ANHYDROUSSalix Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56820SUPPL2018-12-20
56603SUPPL2018-11-30
56602SUPPL2018-11-30
28794SUPPL2012-10-10
23314SUPPL2012-10-09
16529SUPPL2012-10-09
28795SUPPL2011-12-14
21860SUPPL2011-10-10
28793SUPPL2009-11-25
16528SUPPL2009-10-14
28792SUPPL2009-03-27
37835SUPPL2009-03-26
6398SUPPL2008-12-19
42341ORIG2008-09-05
6397SUPPL2007-09-25
28791ORIG2006-03-23
37834ORIG2006-03-22