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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 205749

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NDA 205749 describes ZOLEDRONIC, which is a drug marketed by Gland, Accord Hlthcare, Actavis Inc, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms Inc, Shilpa, Sun Pharma Global, and USV, and is included in thirty-eight NDAs. It is available from one supplier. 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-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for 205749

Tradename:	ZOLEDRONIC
Applicant:	Gland
Ingredient:	zoledronic acid
Patents:	0

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;INTRAVENOUS	205749	ANDA	Gland Pharma Limited	68083-142	68083-142-01	1 VIAL in 1 CARTON (68083-142-01) / 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/100ML
Approval Date:	Jun 29, 2018	TE:	AP	RLD:	No

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