Drugs@FDA: FDA-Approved Drugs

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

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

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