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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219422

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NDA 219422 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 219422

Tradename:	BALSALAZIDE DISODIUM
Applicant:	Pharmobedient
Ingredient:	balsalazide disodium
Patents:	0

Pharmacology for NDA: 219422

Suppliers and Packaging for NDA: 219422

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	219422	ANDA	Carnegie Pharmaceuticals, LLC	80005-126	80005-126-25	280 CAPSULE in 1 BOTTLE (80005-126-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	750MG
Approval Date:	Apr 3, 2025	TE:	AB	RLD:	No

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