Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040349
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFASALAZINE SULFASALAZINE 500MG TABLET;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/2002/040349.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.

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 PHARMACIA AND UPJOHN
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 040349 VINTAGE PHARMS
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 085828 WATSON LABS

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