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

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