Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040349
Company: NUVO PHARMS INC

Products on ANDA 040349

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 040349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2002	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/040349.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/25/2016	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/25/2016	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/22/2013	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/20/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/16/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040349

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	085828	WATSON LABS