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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219342

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NDA 219342 describes CALCIUM CHLORIDE 10%, which is a drug marketed by Am Regent, Amneal, Extrovis, Intl Medication Sys, Medefil Inc, Somerset, Square Pharms Plc, and Hospira, and is included in eight NDAs. It is available from eleven 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. Thirteen suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.

Summary for 219342

Tradename:	CALCIUM CHLORIDE 10%
Applicant:	Extrovis
Ingredient:	calcium chloride
Patents:	0

Pharmacology for NDA: 219342

Mechanism of Action	Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity

Suppliers and Packaging for NDA: 219342

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	219342	ANDA	Dr. Reddy's Laboratories Inc.	75907-223	75907-223-10	10 VIAL, SINGLE-DOSE in 1 CARTON (75907-223-10) / 10 mL in 1 VIAL, SINGLE-DOSE (75907-223-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Nov 27, 2024	TE:	AP	RLD:	No

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