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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219422
Company: CARNEGIE

Products on ANDA 219422

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219422

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219422

BALSALAZIDE DISODIUM

CAPSULE;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077883	APOTEX
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	219422	CARNEGIE
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077806	HIKMA
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	077807	NOVITIUM PHARMA
BALSALAZIDE DISODIUM	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	No	AB	217592	ZYDUS LIFESCIENCES
COLAZAL	BALSALAZIDE DISODIUM	750MG	CAPSULE;ORAL	Prescription	Yes	AB	020610	VALEANT PHARMS INTL

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