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Details for New Drug Application (NDA): 207026

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NDA 207026 describes PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER profile page.

The generic ingredient in PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER is calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate. There are two hundred and fifty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate profile page.

Suppliers and Packaging for NDA: 207026

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate
INJECTABLE;INJECTION 207026 NDA Gambro Renal Products Inc. 24571-116 24571-116-05 2 BAG in 1 CASE (24571-116-05) > 5 L in 1 BAG
PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER
calcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate
INJECTABLE;INJECTION 207026 NDA Gambro Renal Products Inc. 24571-117 24571-117-05 2 BAG in 1 CASE (24571-117-05) > 5 L in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)
Approval Date:Jan 13, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 13, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthN/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)
Approval Date:Jan 13, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 13, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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