Details for New Drug Application (NDA): 204217

NDA 204217 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-one 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-two suppliers are listed for this compound. Additional details are available on the zoledronic acid profile page.

Summary for 204217

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

Pharmacology for NDA: 204217

Suppliers and Packaging for NDA: 204217

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	204217	ANDA	Fresenius Kabi USA, LLC	63323-966	63323-966-00	1 VIAL, GLASS in 1 CARTON (63323-966-00) / 100 mL in 1 VIAL, GLASS
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	204217	ANDA	Gland Pharma Limited	68083-135	68083-135-01	1 VIAL, GLASS in 1 CARTON (68083-135-01) / 100 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 5MG BASE/100ML
Approval Date:	Aug 18, 2016	TE:	AP	RLD:	No

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