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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201783


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NDA 201783 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn, Akorn Inc, Apotex, Aurobindo Pharma Ltd, Bpi Labs Llc, Breckenridge, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Inforlife, Ingenus Pharms Llc, Mylan Labs Ltd, Sagent Pharms Inc, Shilpa Medicare Ltd, Sun Pharma Global, and USV, and is included in thirty-six NDAs. It is available from twenty-five suppliers. Additional details are available on the ZOLEDRONIC ACID profile page.

The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There are twenty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 201783
Tradename:ZOLEDRONIC ACID
Applicant:Emcure Pharms Ltd
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201783
Suppliers and Packaging for NDA: 201783
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 201783 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-170 23155-170-31 1 VIAL, GLASS in 1 CARTON (23155-170-31) > 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/5ML
Approval Date:Mar 12, 2013TE:APRLD:No

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