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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
US Army
Cantor Fitzgerald
Johnson and Johnson

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091561

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NDA 091561 describes CALCIUM ACETATE, which is a drug marketed by Amneal Pharms, Chartwell Rx, Eci Pharms Llc, Heritage Pharms Inc, Invagen Pharms, Lupin Ltd, Nostrum Labs Inc, West-ward Pharms Int, and Paddock Llc, and is included in twelve NDAs. It is available from twenty-seven suppliers. Additional details are available on the CALCIUM ACETATE profile page.

The generic ingredient in CALCIUM ACETATE is calcium acetate. There are two hundred and seventy-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 091561
Applicant:Paddock Llc
Ingredient:calcium acetate
Therapeutic Class:Genitourinary Agents
Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
Pharmacology for NDA: 091561
Suppliers and Packaging for NDA: 091561
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM ACETATE calcium acetate TABLET;ORAL 091561 ANDA Paddock Laboratories, LLC 0574-0113 N 0574-0113-02
CALCIUM ACETATE calcium acetate TABLET;ORAL 091561 ANDA Safecor Health, LLC 48433-300 N 48433-300-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength667MG
Approval Date:Apr 13, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
US Department of Justice
Argus Health

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