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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203135

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NDA 203135 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-five 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-five drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 203135
Tradename:CALCIUM ACETATE
Applicant:Invagen Pharms
Ingredient:calcium acetate
Patents:0
Therapeutic Class:Genitourinary Agents
Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
Pharmacology for NDA: 203135
Suppliers and Packaging for NDA: 203135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM ACETATE calcium acetate CAPSULE;ORAL 203135 ANDA Atlantic Biologicals Corps 17856-0377 N 17856-0377-2
CALCIUM ACETATE calcium acetate CAPSULE;ORAL 203135 ANDA State of Florida DOH Central Pharmacy 53808-1001 N 53808-1001-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength667MG
Approval Date:Feb 7, 2013TE:ABRLD:No

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Medtronic
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Federal Trade Commission
Cantor Fitzgerald
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