Details for New Drug Application (NDA): 203231

NDA 203231 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, 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 203231

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

Pharmacology for NDA: 203231

Suppliers and Packaging for NDA: 203231

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	203231	NDA	Sagent Pharmaceuticals	25021-826	25021-826-82	1 BAG in 1 CARTON (25021-826-82) / 100 mL in 1 BAG
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	203231	NDA	Sagent Pharmaceuticals	25021-826	25021-826-87	5 BAG in 1 CARTON (25021-826-87) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 4MG BASE/100ML
Approval Date:	Aug 2, 2013	TE:	AP	RLD:	Yes

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