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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211553

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NDA 211553 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 211553
Applicant:Medefil Inc
Ingredient:calcium chloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 211553
Suppliers and Packaging for NDA: 211553
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM CHLORIDE 10% calcium chloride INJECTABLE;INJECTION 211553 ANDA Medefil, Inc. 64253-900 64253-900-36 60 SYRINGE, PLASTIC in 1 BOX (64253-900-36) > 10 mL in 1 SYRINGE, PLASTIC (64253-900-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:May 1, 2019TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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