Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021243
Company: PHARMACIA UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZULFIDINE EN-TABS SULFASALAZINE 500MG TABLET; ORAL Prescription None 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
08/18/2000 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21243_Azulfidine.cfm

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