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Generated: December 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207751

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NDA 207751 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn, Akorn Inc, Apotex Inc, Aurobindo Pharma Ltd, Bpi Labs Llc, Breckenridge Pharm, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Inforlife, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty-two NDAs. It is available from twenty-four 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-six suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 207751
Tradename:ZOLEDRONIC ACID
Applicant:Aurobindo Pharma Ltd
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207751
Suppliers and Packaging for NDA: 207751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;IV (INFUSION) 207751 ANDA AuroMedics Pharma LLC 55150-266 55150-266-05 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-266-05) > 5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/5ML
Approval Date:Sep 26, 2016TE:APRLD:No

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