Details for New Drug Application (NDA): 217524

NDA 217524 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 fourteen suppliers. Additional details are available on the CALCIUM CHLORIDE 10% profile page.

The generic ingredient in CALCIUM CHLORIDE 10% is calcium chloride. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the calcium chloride profile page.

Summary for 217524

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

Pharmacology for NDA: 217524

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

Suppliers and Packaging for NDA: 217524

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	217524	ANDA	Amneal Pharmaceuticals LLC	70121-2308	70121-2308-4	24 CARTON in 1 CARTON (70121-2308-4) / 1 SYRINGE, GLASS in 1 CARTON (70121-2308-1) / 10 mL in 1 SYRINGE, GLASS
CALCIUM CHLORIDE 10%	calcium chloride	INJECTABLE;INJECTION	217524	ANDA	Amneal Pharmaceuticals LLC	70121-2309	70121-2309-7	10 VIAL, GLASS in 1 CARTON (70121-2309-7) / 10 mL in 1 VIAL, GLASS (70121-2309-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Jul 8, 2024	TE:	AP	RLD:	No

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