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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Mallinckrodt
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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205279

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NDA 205279 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 205279
Tradename:ZOLEDRONIC ACID
Applicant:Accord Hlthcare
Ingredient:zoledronic acid
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205279
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 205279
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 205279 ANDA Accord Healthcare Inc. 16729-242 16729-242-31 1 VIAL in 1 CARTON (16729-242-31) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:Nov 28, 2016TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
US Department of Justice
Mallinckrodt
Boehringer Ingelheim
Argus Health
Julphar
McKinsey
Federal Trade Commission
Queensland Health

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