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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219046
Company: RISING

Products on ANDA 219046

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFASALAZINE	SULFASALAZINE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219046

SULFASALAZINE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZULFIDINE	SULFASALAZINE	500MG	TABLET;ORAL	Prescription	Yes	AB	007073	PFIZER
SULFASALAZINE	SULFASALAZINE	500MG	TABLET;ORAL	Prescription	No	AB	080197	CHARTWELL
SULFASALAZINE	SULFASALAZINE	500MG	TABLET;ORAL	Prescription	No	AB	040349	NUVO PHARMS INC
SULFASALAZINE	SULFASALAZINE	500MG	TABLET;ORAL	Prescription	No	AB	219046	RISING
SULFASALAZINE	SULFASALAZINE	500MG	TABLET;ORAL	Prescription	No	AB	085828	WATSON LABS

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