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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078998

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NDA 078998 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 ten 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. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for 078998

Tradename:	IBANDRONATE SODIUM
Applicant:	Orbion Pharms
Ingredient:	ibandronate sodium
Patents:	0

Pharmacology for NDA: 078998

Suppliers and Packaging for NDA: 078998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	078998	ANDA	Bionpharma Inc.	69452-378	69452-378-74	1 BLISTER PACK in 1 CARTON (69452-378-74) / 3 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 19, 2012	TE:	AB	RLD:	No

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