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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077807

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NDA 077807 describes BALSALAZIDE DISODIUM, which is a drug marketed by Apotex, Hikma, Novitium Pharma, Pharmobedient, Zydus Lifesciences, and Aarxion Anda Hlding, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the BALSALAZIDE DISODIUM profile page.

The generic ingredient in BALSALAZIDE DISODIUM is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

Summary for 077807

Tradename:	BALSALAZIDE DISODIUM
Applicant:	Novitium Pharma
Ingredient:	balsalazide disodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	750MG
Approval Date:	Dec 28, 2007	TE:	AB	RLD:	No

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