FDA.reportPublic FDA data

Application 013684

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OSMITROL 5% IN WATERMANNITOLINJECTABLE;INJECTION5GM/100MLNoNo
002OSMITROL 10% IN WATERMANNITOLINJECTABLE;INJECTION10GM/100MLNoNo
003OSMITROL 20% IN WATERMANNITOLINJECTABLE;INJECTION20GM/100MLNoNo
004OSMITROL 15% IN WATERMANNITOLINJECTABLE;INJECTION15GM/100MLNoNo
005OSMITROL 5% IN WATER IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION5GM/100MLNoNo
006OSMITROL 10% IN WATER IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION10GM/100MLNoNo
007OSMITROL 20% IN WATER IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION20GM/100MLNoNo
008OSMITROL 15% IN WATER IN PLASTIC CONTAINERMANNITOLINJECTABLE;INJECTION15GM/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0351OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0351OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0353OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0353OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0353OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0353OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0353OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0355OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0355OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0355OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0355OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0355OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0357OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0357OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0357OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0357OsmitrolMannitolBaxter Healthcare CorporationNDACurrent
0338-0357OsmitrolMannitolBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59583SUPPL2019-08-06
59604SUPPL2019-08-05
56544SUPPL2018-11-23
56543SUPPL2018-11-23
56488SUPPL2018-11-16
56486SUPPL2018-11-16
12053SUPPL2005-09-07
10833SUPPL2005-09-07
33108SUPPL2005-06-14
12052SUPPL2005-06-14