Last Updated: November 8, 2026

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, Adaptis, Amneal, Apotex, Avet Lifesciences, Bpi Labs, Breckenridge, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma Farmaceutica, Hospira, Hospira Inc, Inforlife, Ingenus Pharms Llc, Meitheal, Mylan Labs Ltd, Sagent Pharms Inc, Sun Pharma Global, and USV, and is included in thirty-eight NDAs. It is available from twenty-one suppliers. Additional details are available on the ZOLEDRONIC ACID profile page.

The generic ingredient in ZOLEDRONIC ACID is zoledronic acid. There is one drug master file entry for this compound. Twenty-two 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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