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Last Updated: April 21, 2025

Details for New Drug Application (NDA): 202548

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NDA 202548 describes ZOLEDRONIC ACID, which is a drug marketed by 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, Gland, Gland Pharma Ltd, 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-seven NDAs. It is available from twenty-two 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 202548

Tradename:	ZOLEDRONIC ACID
Applicant:	Epic Pharma Llc
Ingredient:	zoledronic acid
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/5ML
Approval Date:	May 22, 2014	TE:	AP	RLD:	No

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