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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 007073
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZULFIDINE SULFASALAZINE 500MG TABLET;ORAL Prescription AB Yes Yes
AZULFIDINE EN-TABS SULFASALAZINE 500MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2021 SUPPL-130 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007073s130lbl.pdf
01/15/2021 SUPPL-129 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007073s129lbl.pdf
03/04/2014 SUPPL-128 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/007073s128lbl.pdf
07/18/2013 SUPPL-126 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007073s126lbl.pdf
12/12/2012 SUPPL-125 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/007073s125lbl.pdf
10/19/2009 SUPPL-124 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/007073s124lbl.pdf
08/17/2001 SUPPL-115 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/7073s115lbl.pdf
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