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Generated: January 20, 2019

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Details for New Drug Application (NDA): 205749

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NDA 205749 describes ZOLEDRONIC, which is a drug marketed by Gland Pharma Ltd, 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, Hikma Farmaceutica, Hospira Inc, Inforlife, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Usv North America, and is included in thirty-four NDAs. It is available from two suppliers. Additional details are available on the ZOLEDRONIC profile page.

The generic ingredient in ZOLEDRONIC 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 205749
Tradename:ZOLEDRONIC
Applicant:Gland Pharma Ltd
Ingredient:zoledronic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205749
Suppliers and Packaging for NDA: 205749
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZOLEDRONIC zoledronic acid INJECTABLE;IV (INFUSION) 205749 ANDA Gland Pharma Limited 68083-142 68083-142-01 1 VIAL in 1 CARTON (68083-142-01) > 100 mL in 1 VIAL
ZOLEDRONIC zoledronic acid INJECTABLE;IV (INFUSION) 205749 ANDA Athenex Pharmaceutical Division, LLC. 70860-210 70860-210-51 1 VIAL, SINGLE-USE in 1 CARTON (70860-210-51) > 100 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)StrengthEQ 4MG BASE/100ML
Approval Date:Jun 29, 2018TE:APRLD:No

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