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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 209088

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NDA 209088 describes CALCIUM CHLORIDE 10%, which is a drug marketed by Am Regent, Intl Medication Sys, Medefil Inc, and Hospira, and is included in four NDAs. It is available from three suppliers. Additional details are available on the CALCIUM CHLORIDE 10% profile page.

The generic ingredient in CALCIUM CHLORIDE 10% is calcium chloride. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.
Summary for 209088
Applicant:Am Regent
Ingredient:calcium chloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 209088
Suppliers and Packaging for NDA: 209088
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM CHLORIDE 10% calcium chloride INJECTABLE;INJECTION 209088 ANDA American Regent, Inc. 0517-6710 0517-6710-10 10 VIAL, GLASS in 1 BOX (0517-6710-10) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jul 27, 2017TE:APRLD:No

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