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Details for New Drug Application (NDA): 020161

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NDA 020161 describes POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Hospira and is included in two NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER is potassium chloride. There are two hundred and twenty-five drug master file entries for this compound. Seventy-one suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the potassium chloride profile page.

Summary for NDA: 020161

Tradename:
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
Applicant:
Hospira
Ingredient:
potassium chloride
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details

Pharmacology for NDA: 020161

Ingredient-typePotassium Compounds

Suppliers and Packaging for NDA: 020161

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
potassium chloride
INJECTABLE;INJECTION 020161 NDA Hospira, Inc. 0409-7074 0409-7074-26 24 POUCH in 1 CASE (0409-7074-26) > 1 BAG in 1 POUCH > 100 mL in 1 BAG
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
potassium chloride
INJECTABLE;INJECTION 020161 NDA Hospira, Inc. 0409-7075 0409-7075-14 24 POUCH in 1 CASE (0409-7075-14) > 1 BAG in 1 POUCH > 50 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength745MG/100ML
Approval Date:Nov 30, 1992TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.49GM/100ML
Approval Date:Nov 30, 1992TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.24GM/100ML
Approval Date:Aug 11, 1998TE:APRLD:Yes


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