FDA.reportPublic FDA data

Application 207026

Type
NDA
Sponsor
BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINERCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATEINJECTABLE;INJECTION3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)YesYes
002PHOXILLUM B22K 4/0 IN PLASTIC CONTAINERCALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATEINJECTABLE;INJECTIONN/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-116PHOXILLUMcalcium chloride, magnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent
24571-117PHOXILLUMmagnesium chloride, sodium chloride, sodium bicarbonate, potassium chloride and sodium phosphate dibasic dihydrateBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74162SUPPL 2023-05-03
74156SUPPL 2023-05-03
56243SUPPL2018-12-06
56296SUPPL2018-11-06
48904SUPPL2017-07-05
48891SUPPL2017-07-03
32839SUPPL2016-07-22
19955SUPPL2016-07-21
19954SUPPL2015-12-17
10608SUPPL2015-12-17
44954ORIG2015-04-07
43530ORIG2015-04-07
10607ORIG2015-01-15
40577ORIG2015-01-14