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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 203477

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NDA 203477 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 203477
Applicant:Intl Medication Sys
Ingredient:calcium chloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 203477
Suppliers and Packaging for NDA: 203477
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM CHLORIDE 10% calcium chloride INJECTABLE;INJECTION 203477 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1379 51662-1379-1 1 SYRINGE in 1 CARTON (51662-1379-1) > 10 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:May 9, 2018TE:APRLD:No

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