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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Federal Trade Commission
Daiichi Sankyo
Healthtrust
Farmers Insurance
Merck
Baxter
Chinese Patent Office

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203231

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NDA 203231 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 203231
Tradename:ZOLEDRONIC ACID
Applicant:Inforlife
Ingredient:zoledronic acid
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203231
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 203231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 203231 NDA Sagent Pharmaceuticals 25021-826 N 25021-826-67
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 203231 NDA Sagent Pharmaceuticals 25021-826 N 25021-826-66

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/100ML
Approval Date:Aug 2, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Chinese Patent Office
McKinsey
Queensland Health
Cerilliant
Boehringer Ingelheim
Accenture
Chubb
Merck

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