Last Updated: September 24, 2026

Details for New Drug Application (NDA): 079003

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NDA 079003 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, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in sixteen NDAs. It is available from nine suppliers. Additional details are available on the IBANDRONATE SODIUM profile page.

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

Summary for 079003

Tradename:	IBANDRONATE SODIUM
Applicant:	Watson Labs Teva
Ingredient:	ibandronate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 20, 2012	TE:		RLD:	No

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