Last Updated: November 13, 2026

Details for New Drug Application (NDA): 204329

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NDA 204329 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 204329

Tradename:	IBANDRONATE SODIUM
Applicant:	Nang Kuang Pharm Co
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:	Jun 16, 2021	TE:		RLD:	No

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