Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075339
Company: NUVO PHARMS INC

Products on ANDA 075339

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075339

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/2002/075339.PDF

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/18/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/18/2015	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.
10/03/2012	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/13/2004	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075339

SULFASALAZINE

TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZULFIDINE EN-TABS	SULFASALAZINE	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	007073	PFIZER
SULFASALAZINE	SULFASALAZINE	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	075339	NUVO PHARMS INC