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Generated: November 22, 2018

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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 thirty-eight drug master file entries for this compound. Seventy-eight suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.
Summary for 088901
Tradename:POTASSIUM CHLORIDE IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:potassium chloride
Patents:0
Formulation / Manufacturing:see details
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 Fresenius Kabi USA, LLC 63323-965 63323-965-05 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-965-05) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-965-01)

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
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Merck
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