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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208513

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NDA 208513 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn, Akorn Inc, Apotex Inc, 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, Mylan Labs Ltd, Sagent Pharms, Shilpa Medicare Ltd, Sun Pharma Global, and USV, and is included in thirty-five NDAs. It is available from twenty-three 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-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 208513
Tradename:ZOLEDRONIC ACID
Applicant:Shilpa Medicare Ltd
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/5ML
Approval Date:May 15, 2019TE:APRLD:No

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