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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204016

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NDA 204016 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, Dr Reddys Labs Ltd, Pharmaceutics, Apotex Inc, PII, Actavis Inc, Accord Hlthcare, Hikma Farmaceutica, and Sagent Pharms, and is included in twenty-eight NDAs. It is available from nineteen 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 suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for NDA: 204016

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

Pharmacology for NDA: 204016

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 204016

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID
zoledronic acid
SOLUTION;IV (INFUSION) 204016 NDA Hospira, Inc. 0409-4229 0409-4229-01 1 BAG in 1 CARTON (0409-4229-01) > 100 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)StrengthEQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)
Approval Date:Dec 28, 2015TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Teva
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Fuji
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Fish and Richardson
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