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Generated: January 20, 2019

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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 Intl Medication Sys, Luitpold, and Hospira, and is included in three NDAs. It is available from two 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. Six 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 International Medication Systems, Limited 76329-3304 76329-3304-1 10 SYRINGE in 1 PACKAGE (76329-3304-1) > 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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