Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018605
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZULFIDINE SULFASALAZINE 250MG/5ML SUSPENSION;ORAL Discontinued 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
12/29/1980 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/1990 SUPPL-10 Labeling

Label is not available on this site.

12/19/1983 SUPPL-9 Labeling

Label is not available on this site.

02/05/1985 SUPPL-6 Labeling

Label is not available on this site.

07/21/1981 SUPPL-3 Labeling

Label is not available on this site.

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