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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091493

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NDA 091493 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, Breckenridge Pharm, Dr Reddys Labs Ltd, Apotex Inc, Actavis Inc, Accord Hlthcare, Hikma Farmaceutica, and Sagent Pharms, and is included in twenty-eight NDAs. It is available from twenty-one 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-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for 091493

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

Pharmacology for NDA: 091493

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 091493

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 091493 ANDA Sagent Pharmaceuticals 25021-801 25021-801-66 1 VIAL in 1 CARTON (25021-801-66) > 5 mL in 1 VIAL
ZOLEDRONIC ACID
zoledronic acid
INJECTABLE;IV (INFUSION) 091493 ANDA Sagent Pharmaceuticals 25021-801 25021-801-67 1 VIAL in 1 CARTON (25021-801-67) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:Nov 24, 2014TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

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Queensland Health
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McKinsey

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