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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 090853

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NDA 090853 describes IBANDRONATE SODIUM, which is a drug marketed by Accord Hlthcare, Apotex, Avet Lifesciences, Chemi Spa, Eugia Pharma, Nang Kuang Pharm Co, Pharmobedient, Sun Pharm, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in sixteen NDAs. It is available from eleven suppliers. Additional details are available on the IBANDRONATE SODIUM profile page.

The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for 090853

Tradename:	IBANDRONATE SODIUM
Applicant:	Sun Pharm
Ingredient:	ibandronate sodium
Patents:	0

Pharmacology for NDA: 090853

Suppliers and Packaging for NDA: 090853

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	090853	ANDA	Sun Pharmaceutical Industries, Inc.	62756-218	62756-218-40	1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) / 3 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 3MG BASE/3ML
Approval Date:	Feb 14, 2014	TE:		RLD:	No

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