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BioPharmaceutical Business Intelligence

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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202163

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NDA 202163 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 202163

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

Pharmacology for NDA: 202163

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 202163

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202163 ANDA Par Pharmaceutical Companies, Inc. 42023-163 42023-163-01 1 BOTTLE in 1 CARTON (42023-163-01) > 100 mL in 1 BOTTLE
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 202163 ANDA Breckenridge Pharmaceutical, Inc 51991-064 51991-064-98 1 CONTAINER in 1 CARTON (51991-064-98) > 100 mL in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 5MG BASE/100ML
Approval Date:Aug 5, 2013TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Novartis
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Julphar
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Harvard Business School
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Baxter
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