FDA Approval Activities for this Drug…

Azulfidine EN-tabs (sulfasalazine) Tablets, 500 mg, Pharmacia & Upjohn NDA 21-243 8/18/00 7/18/01 7/18/01 7/18/01 Azulfidine Indications: for the treatment of pediatric patients with polyarticular course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs. Azulfidine EN-tabs (sulfasalazine) Tablets, 500 mg, Pharmacia & Upjohn NDA 7-073/S-120 7/30/02 8/6/02 Azulfidine EN-tabs (sulfasalazine) Tablets, 500 mg, Pharmacia & Upjohn NDA 7-073/S-115 Sulfasalazine Delayed-Release Tablets, 500 mg, Sulfasalazine Delayed-Release Tablets, Vintage ANDA 75-339 1/11/02 Sulfasalazine Tablets, 500 mg, Vintage ANDA 40-349 SULFASALAZINE Suspension; 250MG/5ML AZULFIDINE PHARMACIA AND UPJOHN 007073 SULFASALAZINE Tablet, Delayed Release; 500MG AZULFIDINE EN-TABS PHARMACIA AND UPJOHN 075339 SULFASALAZINE Tablet, Delayed Release; 500MG SULFASALAZINE Vintage 089590 SULFASALAZINE Tablet; 500MG SULFASALAZINE Mutual 007073 SULFASALAZINE Tablet; 500MG AZULFIDINE PHARMACIA AND UPJOHN 040349 SULFASALAZINE Tablet; 500MG SULFASALAZINE Vintage 085828 SULFASALAZINE Tablet; 500MG SULFASALAZINE Watson 087197 SULFASALAZINE Tablet; 500MG SULFASALAZINE Watson

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