Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202235

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NDA 202235 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 202235

Tradename:	IBANDRONATE SODIUM
Applicant:	Chemi Spa
Ingredient:	ibandronate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	EQ 3MG BASE/3ML
Approval Date:	Sep 2, 2014	TE:		RLD:	No

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