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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Queensland Health
Dow
McKesson
Express Scripts
Johnson and Johnson
Covington
Argus Health
Mallinckrodt

Generated: April 23, 2018

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 Inc, Aurobindo Pharma Ltd, Bpi Labs Llc, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Inforlife, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty-two NDAs. It is available from twenty 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-one 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
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201783
Ingredient-typeDiphosphonates
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;IV (INFUSION) 201783 ANDA Heritage Pharmaceuticals Inc. 23155-170 N 23155-170-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:Mar 12, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
McKesson
Boehringer Ingelheim
McKinsey
Deloitte
US Army
Baxter
UBS

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