Details for New Drug Application (NDA): 091363

NDA 091363 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 091363

Tradename:	ZOLEDRONIC ACID
Applicant:	Dr Reddys Labs Ltd
Ingredient:	zoledronic acid
Patents:	0

Pharmacology for NDA: 091363

Suppliers and Packaging for NDA: 091363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	091363	ANDA	Dr.Reddy's Laboratories Inc	43598-331	43598-331-11	100 mL in 1 BOTTLE, GLASS (43598-331-11)
ZOLEDRONIC ACID	zoledronic acid	INJECTABLE;INTRAVENOUS	091363	ANDA	Dr.Reddy's Laboratories Ltd	55111-688	55111-688-52	100 mL in 1 BOTTLE, GLASS (55111-688-52)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 5MG BASE/100ML
Approval Date:	Mar 29, 2013	TE:	AP	RLD:	No

Complete Access Available with Subscription