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FDA Approval Activities for this Drug…
Topamax (topiramate capsules) Sprinkle Capsules, R.W. Johnson NDA 20-844 10/26/98 1/8/99 1/8/99 | Topamax Indication: As adjunctive therapy in the treatment of adults with partial onset seizures | Topamax (topiramate) Tablets & Sprinkle Capsules, Ortho-McNeil Pharmaceutical, NDA 20-505/S21, S23 & 20-844/S18, S20 4/15/03 7/30/03 | Topamax (topiramate) Tablets & Sprinkle Capsules, Ortho-McNeil Pharmaceutical, NDA 20-505/S-020 & 20-844/S-017 6/12/03 7/8/03 | Topamax (topiramate) Tablets & Sprinkle Capsules, Ortho-McNeil Pharmaceutical, NDA 20-505/S-016 & 20-844/S-013 11/26/02 12/9/02 | Topamax (topiramate) Tablets & Sprinkle Capsules, Ortho-McNeil Pharmaceutical NDA 20-505/S-015 & 20-844/S-012 6/3/03 | Topamax (topiramate) Tablets & Topamax (topiramate capsules) Sprinkle Capsules, R.W. Johnson NDA 20-505/S-003 & NDA 20-844/S-004 10/1/99 7/3/00 7/3/00 | Topamax (topiramate) Tablets & Topamax (topiramate) Sprinkle Capsules, R.W. Johnson NDA 20-505/S-002 & NDA 20-844/S-010 8/28/01 9/5/01 9/5/01 | Topamax (topiramate) Tablets & Topamax (topiramate capsules) Sprinkle Capsules, R.W. Johnson Pharmaceutical Research NDA 20-505/S-001 & NDA 20-844/S-001 7/23/99 7/3/00 7/3/00 | Topamax Indication: These efficacy supplements provide for the use of Topamax as adjunctive therapy in pediatric patients ages 2 - 16 years with partial onset seizures. | Topamax Indications: These efficacy supplements provide for the use of Topamax as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures. Topiramate Tablets, 25, 100 & 200 mg, Ivax | ANDA 76-343 9/26/03 Topiramate Tablets, 25, 100 & 200 mg, Mylan | ANDA 76-314 4/23/03 Topiramate Tablets, 25, 100 & 200 mg, Par | ANDA 76-311 10/22/03 Topiramate Tablets, 25, 100 & 200 mg, Roxane, ANDA 76-306 Topiramate Tablets, Par | Topamax (topiramate) Tablets & Sprinkle Capsules, Ortho-McNeil Pharmaceutical, Inc. Topiramate Capsules, Barr | Pharmaceuticals, Topamax (topiramate) sprinkle capsules, R.W. Johnson, Labeling Revision Topamax (topiramate) tablets, R.W. Johnson, New or Modified Indication | Topiramate Tablets, Teva Pharma, Tentative Approval | Topiramate Tablets, Roxane Labs, Tentative Approval | Topiramate Capsules, Teva Pharma, Tentative Approval | Topamax (topiramate) Tablets, Ortho-McNeil Pharmaceutical, Inc. Efficacy supplement - New Indication | Topamax (topiramate capsules) Sprinkle Capsules Capsules, Ortho-McNeil Pharmaceutical, Inc., Efficacy supplement - New Indication | Topiramate Tablets, Teva Pharma, Tentative Approval | Topiramate Tablets, Par Pharma, Tentative Approval | Topiramate Tablets, Mylan Pharma, Approval | Topiramate hydrochloride Tablets, Cobalt Pharma, Tentative Approval | Topamax Tablets, Ortho-McNeil Pharma, Labeling Revision | Topamax Sprinkle Capsules, Ortho-McNeil Pharma, Labeling Revision | Topiramate Tablets, Zydus Pharma, Tentative Approval | Topiramate Tablets, Glenmark Pharma, Tentative Approval | Topiramate Capsules, Mylan Pharma, Tentative Approval | Topiramate Tablets, Aurobindo Pharma, Tentative Approval | Topiramate Tablets, Cobalt Labs, Tentative Approval | Topiramate Tablets, Apotex, Tentative Approval | Topiramate Capsules, Cobalt Laboratories, Inc., Tentative Approval | Topiramate Tablets, Cipla Ltd., Tentative Approval | Topiramate Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval | Topiramate Tablets, Sun Pharmaceutical Industries Ltd., Approval | Topiramate Tablets, Pliva HRVATSKA d.o.o., Approval | Topiramate Tablets, Mylan Pharmaceuticals Inc., Approval | Topiramate Tablets, Cobalt Laboratories, Inc., Approval | Topiramate Tablets, Glenmark Generics Ltd., Approval | Topiramate Tablets, Apotex Inc., Approval | Topiramate Tablets, Zydus Pharmaceuticals USA Inc., Approval | Topiramate Tablets, Roxane Laboratories, Inc., Approval | Topiramate Tablets, Barr Laboratories, Inc., Approval | Topiramate Tablets, Ranbaxy Laboratories Ltd., Approval | Topiramate Tablets, Unichem Laboratories Ltd., Approval | Topiramate Tablets, Aurobindo Pharma Ltd., Approval | Topiramate Tablets, TEVA Pharmaceuticals USA, Approval | Topiramate Tablets, Torrent Pharma Inc., Approval | Topiramate Tablets, Cipla Ltd., Approval | Topiramate Tablets, InvaGen Pharmaceuticals, Inc., Approval| Topiramate Capsules, Teva Pharmaceuticals USA, Approval | Topiramate Capsules, Barr Laboratories, Inc., Approval | Topiramate Capsules, Zydus Pharmaceuticals USA Inc., Tentative Approval | Topiramate Capsules, Sandoz Inc., Tentative Approval | Topiramate Capsules, Cobalt Laboratories Inc., Approval | Topamax (topiramate) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Topamax (topiramate) Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Topamax (topiramate) Tablets, Johnson & Johnson Pharmaceutical, Labeling Revision | Topamax (topiramate) Sprinkle Capsules, Johnson & Johnson Pharmaceutical, Labeling Revision | Topiramate Capsules, Sandoz Inc., Approval | Topiramate Capsules, Zydus Pharmaceuticals Inc., Approval | Topiramate Capsules, Mylan Pharmaceuticals Inc., Approval | Topiramate Capsules, Mylan Pharmaceuticals Inc., Approval | Topamax (topiramate) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision and Efficacy Supp. | Topamax (topiramate) Sprinkle Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision and Efficacy Supp. | Topiramate Tablets, Upsher-Smith Laboratories, Inc., Approval | Topiramate Tablets, Wockhardt, Ltd., Approval | Topamax (topiramate) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Topamax Sprinkle (topiramate) Capsules, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision | Topamax Sprinkle (topiramate) Capsules, Janssen Pharmaceuticals, Inc., Approval | Topamax (topiramate) Tablets, Janssen Pharmaceuticals, Inc., Approval | Topamax (topiramate) Tablets, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Efficacy Supplement with Clinical Data to Support | Topamax Sprinkle (topiramate) Capsules, Johnson & Johnson Pharmaceutical Research & Development, L.L.C, Efficacy Supplement with Clinical Data to Support
  
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