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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 077807

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NDA 077807 describes BALSALAZIDE DISODIUM, which is a drug marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus Lifesciences, and Strides Pharma, and is included in five NDAs. It is available from eight 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:	Dash Pharms Natco
Ingredient:	balsalazide disodium
Patents:	0

Profile for product number 001

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

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