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FDA Approval Activities for this Drug…
Celebrex (Celecoxib) Capsules, Pharmacia NDA 20-998/S013 8/29/02 8/30/02 Celebrex Capsules, 100 mg, G. D. Searle & Co. NDA 20-998/S010 10/18/01 11/5/01 11/5/01 Celebrex (celecoxib) Capsules, 100 mg and 200 mg, G.D. Searle L.L.C. NDA 20-998/S9 6/7/02 6/17/02 6/7/02 8/29/02 CELEBREX (celecoxib capsules), 100 mg and 200 mg, G.D. Searle NDA 20-998 12/31/98 1/5/99 1/5/99 6/9/99 Celebrex (Celecoxib) Capsules, Pharmacia NDA 21-156/S1 & S2 8/29/02 8/30/02 Celebrex Capsules, G. D. Searle & Co. NDA 21-156 & 20-998/S007 12/23/99 12/27/99 12/27/99 6/18/01 Celebrex Indication: To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance , surgery). | Celebrex (Celecoxib) Capsules, Pfizer, Labeling Revision | Celebrex (celecoxib) capsules, Pfizer Global Pharma, Labeling Revision | Celebrex (celecoxib) Capsules, Pfizer, New or Modified Indication & Labeling Revision | CELEBREX (celecoxib) Capsules, G.D. Searle, Labeling Revision | CELEBREX (celecoxib) Capsules, G.D. Searle, Labeling Revision | CELEBREX (Celecoxib) Capsules, G.D. Searle, Labeling Revision | Celebrex (celecoxib) Capsules, Pfizer Inc., New Dosage Regimen | Celebrex (celecoxib) Capsules, Pfizer, Inc., Labeling Revision | Celecoxib Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
  
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