Details for New Drug Application (NDA): 201783

NDA 201783 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 201783

Tradename:	ZOLEDRONIC ACID
Applicant:	Avet Lifesciences
Ingredient:	zoledronic acid
Patents:	0

Pharmacology for NDA: 201783

Suppliers and Packaging for NDA: 201783

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	201783	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-170	23155-170-31	1 VIAL, GLASS in 1 CARTON (23155-170-31) / 5 mL in 1 VIAL, GLASS
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	201783	ANDA	BluePoint Laboratories	68001-610	68001-610-25	1 VIAL, GLASS in 1 CARTON (68001-610-25) / 5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/5ML
Approval Date:	Mar 12, 2013	TE:	AP	RLD:	No

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