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Serving leading biopharmaceutical companies globally:

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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202650

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NDA 202650 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Acs Dobfar Info Sa, Actavis Inc, Akorn, Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty NDAs. It is available from twenty-two 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-three suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 202650
Tradename:ZOLEDRONIC ACID
Applicant:Mylan Labs Ltd
Ingredient:zoledronic acid
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202650
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 202650
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202650 ANDA Amneal-Agila, LLC 53150-871 53150-871-01 1 VIAL, SINGLE-USE in 1 CARTON (53150-871-01) > 5 mL in 1 VIAL, SINGLE-USE
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202650 ANDA Mylan Institutional LLC 67457-390 67457-390-54 1 VIAL in 1 CARTON (67457-390-54) > 5 mL in 1 VIAL

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Dow
McKinsey
Medtronic
Harvard Business School
Daiichi Sankyo
UBS
McKesson

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