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Details for New Drug Application (NDA): 088901

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NDA 088901 describes POTASSIUM CHLORIDE IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Kabi Usa and is included in two NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 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: 088901

Tradename:
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
Applicant:
Fresenius Kabi Usa
Ingredient:
potassium chloride
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details

Pharmacology for NDA: 088901

Ingredient-typePotassium Compounds

Suppliers and Packaging for NDA: 088901

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
potassium chloride
INJECTABLE;INJECTION 088901 ANDA General Injectables & Vaccines, Inc 52584-965 52584-965-05 1 VIAL, SINGLE-DOSE in 1 BAG (52584-965-05) > 5 mL in 1 VIAL, SINGLE-DOSE
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
potassium chloride
INJECTABLE;INJECTION 088901 ANDA General Injectables & Vaccines, Inc 52584-965 52584-965-10 1 VIAL, SINGLE-DOSE in 1 BAG (52584-965-10) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MEQ/ML
Approval Date:Jan 25, 1985TE:APRLD:No


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