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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

McKinsey
Covington
UBS
Mallinckrodt
Healthtrust
Teva
Fuji
Deloitte
Fish and Richardson
Federal Trade Commission

Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091170

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NDA 091170 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 091170

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091170

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 091170

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091170 ANDA Par Pharmaceutical Companies, Inc. 42023-151 42023-151-01 1 VIAL, PLASTIC in 1 CARTON (42023-151-01) > 5 mL in 1 VIAL, PLASTIC
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 091170 ANDA Breckenridge Pharmaceutical, Inc 51991-065 51991-065-98 1 VIAL in 1 CARTON (51991-065-98) > 5 mL in 1 VIAL

Summary 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:

Citi
Harvard Business School
Daiichi Sankyo
Johnson and Johnson
Cantor Fitzgerald
Queensland Health
Argus Health
Federal Trade Commission
QuintilesIMS
Chinese Patent Office

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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