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Last Updated: September 20, 2020

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Details for New Drug Application (NDA): 205279

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NDA 205279 describes ZOLEDRONIC ACID, which is a drug marketed by Accord Hlthcare, Actavis Inc, Akorn, Akorn Inc, Apotex, Aurobindo Pharma Ltd, Bpi Labs Llc, Breckenridge, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira Inc, Inforlife, Ingenus Pharms Llc, Mylan Labs Ltd, Puniska, Sagent Pharms Inc, Shilpa Medicare Ltd, Sun Pharma Global, and USV, and is included in thirty-six NDAs. It is available from twenty-three 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-four suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.
Summary for 205279
Tradename:ZOLEDRONIC ACID
Applicant:Accord Hlthcare
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205279
Suppliers and Packaging for NDA: 205279
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 205279 ANDA Northstar RxLLC 16714-815 16714-815-01 1 VIAL in 1 CARTON (16714-815-01) > 5 mL in 1 VIAL
ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 205279 ANDA Accord Healthcare Inc. 16729-242 16729-242-31 1 VIAL in 1 CARTON (16729-242-31) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 4MG BASE/5ML
Approval Date:Nov 28, 2016TE:APRLD:No

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