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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091186

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NDA 091186 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: 091186

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

Pharmacology for NDA: 091186

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 091186

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 091186 ANDA Dr. Reddy's Laboratories Inc. 43598-330 43598-330-11 1 VIAL, GLASS in 1 CARTON (43598-330-11) > 5 mL in 1 VIAL, GLASS
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 091186 ANDA Dr. Reddy's Laboratories Limited 55111-685 55111-685-07 1 VIAL, GLASS in 1 CARTON (55111-685-07) > 5 mL in 1 VIAL, GLASS

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 500+ biopharmaceutical companies globally:

Harvard Business School
Cerilliant
Dow
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Deloitte
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Fish and Richardson
Chinese Patent Office

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