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Serving leading biopharmaceutical companies globally:

AstraZeneca
Healthtrust
Argus Health
Chubb
Daiichi Sankyo
Federal Trade Commission
Queensland Health
Baxter
QuintilesIMS
Deloitte

Generated: October 17, 2017

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 Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira Inc, Gland Pharma Ltd, Akorn, Sun Pharma Global, Usv North America, Acs Dobfar Info Sa, Mylan Labs Ltd, Akorn Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Apotex Inc, Actavis Inc, Accord Hlthcare, Hikma Farmaceutica, and Sagent Pharms, and is included in twenty-eight 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 NDA: 203231

Tradename:
1
Applicant:
1
Ingredient:
1
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 25021-826-67 1 BAG in 1 CARTON (25021-826-67) > 100 mL in 1 BAG
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 203231 NDA Sagent Pharmaceuticals 25021-826 25021-826-66 1 BAG in 1 CARTON (25021-826-66) > 100 mL in 1 BAG

Summary 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 leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Chinese Patent Office
Fish and Richardson
Teva
McKinsey
Novartis
Daiichi Sankyo
Farmers Insurance
Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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