|
|
|
 |
FDA Approval Activities for this Drug…
Gabapentin Capsules, 100, 300 & 400 mg, Approvable Eon Labs Manufacturing ANDA 75-539 4/25/02 | Gabapentin Capsules, 100, 300 & 400 mg, Approvable Ivax ANDA 75-477 4/29/02 | Gabapentin Capsules, 100, 300 & 400 mg, Teva ANDA 75-435 8/7/03 | Gabapentin Capsules, 100, 300 & 400 mg, Approvable Teva ANDA 75-435 7/18/02 | Gabapentin Capsules, 100, 300 & 400 mg, Torpharm ANDA 75-360 1/29/03 | Gabapentin Capsules, 100, 300 & 400 mg, Purepac ANDA 75-350 9/12/03 | Gabapentin Capsules, 100, 300 & 400 mg, Approvable Purepac Pharmaceutical Co. ANDA 75-350 4/25/02 | Gabapentin Tablets, 600 & 800 mg, Teva ANDA 75-827 10/17/03 | Gabapentin Tablets, 600 & 800 mg, Approvable Purepac Pharmaceutical Co. ANDA 75-694 Neurontin (gabapentin) tablets, capsules and oral solution, Parke-Davis Pharmaceutical Research NDA 21-397, 21-423 & 21-424 5/24/02 6/3/02 5/28/02 | Neurontin (gabapentin) Capsules, Parke-Davis NDA 20-235 | /S11 9/29/98 1/8/99 1/8/99 7/14/99 | Neurontin Indication: As adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy. | Neurontin (gabapentin) Capsules, Tablets, and Solution, Parke-Davis Ltd. NDA 20-235/S-023, 20-882/S-009, 21-129/S-010 8/15/02 8/21/02 | Neurontin (gabapentin) Capsules, Tablets, and Solution, Pfizer NDA 20-235/S-022, 20-882/S-008, 21-129/S-009 & 21-216/S-001 1/30/02 3/6/02 | Neurontin (gabapentin) oral solution, capsule & tablet, Parke-Davis Pharmaceutical Research NDA 21-216, 20-235/S015, 20-882/S002 10/11/00 11/16/00 11/16/00 | Neurontin Indication: Adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. | Neurontin (gabapentin) oral solution,Rx Parke-Davis Pharmaceutical Research NDA 21-129 3/2/00 | Neurontin Indication: Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy (This NDA provided bioequivalency data to support an oral liquid dosage form of gabapentin for the same indications as the already approved Neurontin capsule.) | | Neurontin (gabapentin) Tablets, 600 and 800 mg, Parke-Davis NDA 20-882 10/9/98 10/13/98 12/14/98 | Neurontin Indication:Anticonvulsant Gabapentin Capsules, Ivax, Gabapentin Tablets, Ivax Pharmaceuticals, Split Approval/ Neurontin (gabapentin) Tablets, Pfizer, Inc. Gabapentin Capsule, Ranbaxy, Tentative Approval | Gabapentin Capsules, Mutual Pharmaceutical, Tentative Approval | Gabapentin Capsules, Teva Pharma, Approval | Gabapentin Capsules, Watson Labs, Tentative Approval | Gabapentin Tablets, Purepac Pharma, Approval | Gabapentin Tablets, Ranbaxy Labs, Tentative Approval | Gabapentin Tablets, Eon Labs, Tentative Approval | Neurontin (gabapentin) Capsules, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) Tablets, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) Oral Solution, Pfizer Inc., Labeling Revision | Gabapentin Capsules, Apotex Inc., Approval | Gabapentin Capsules, Eon Pharma, Approval | Gabapentin Tablets, IVAX Pharma, Supplement | Gabapentin Capsules, Mutual Pharmaceutical Company, Inc., Approval | Gabapentin Capsules, Taro Pharma, Tentative Approval 077261 | Gabapentin Tablets, Ranbaxy Labs, Approval | Gabapentin Capsules, Ranbaxy Labs, Approval | Gabapentin Capsules, Sandoz, Approval | Gabapentin Tablets, Sandoz, Approval | Neurontin (gabapentin) capsules, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) tablets, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) oral solution, Pfizer Inc., Labeling Revision | Gabapentin Capsules, Sun Pharma, Tentative Approval | Gabapentin Tablets, Sun Pharma, Tentative Approval | Gabapentin Tablets, Sandoz, Inc., Approval | Gabapentin Tablets, Glenmark Pharma, Approval | Gabapentin Capsules, Sun Pharmaceuticals, Approval | Gabapentin Tablets, Sun Pharmaceuticals, Approval | Gabapentin Tablets, Apotex Inc., Approval | Gabapentin Tablets, Apotex Inc., Approval | Gabapentin Capsules, Apotex Inc., Labeling | Gabapentin Capsules, Interpharm Inc., Approval | Gabapentin Capsules, Hikma Pharma, Approval | Gabapentin Capsules, Aurobindo Pharma, Approval | Gabapentin Tablets, Zydus Pharma, Tentative Approval | Neurontin (gabapentin) Capsules, Pfizer, Inc., Labeling Revision | Neurontin (gabapentin) Tablets, Pfizer, Inc., Labeling Revision | Neurontin (gabapentin) Oral Solution, Pfizer, Inc., Labeling Revision | Gabapentin Capsules, InvaGen Pharmaceuticals, Approval | Gabapentin Tablets, Matrix Laboratories Ltd., Approval | Neurontin (gabapentin) Capsules, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) Oral Solution, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) Tablets, Pfizer Inc., Labeling Revision | Gabapentin Capsules, Alkem Laboratories Ltd., Approval | Gralise (gabapentin) Tablets, Abbott Products, Inc., Approval | Gabapentin Capsules, Matrix Laboratories Ltd., Approval | Gabapentin Tablets, Zydus Pharmaceuticals, Approval | Gabapentin Oral Solution, Hi-Tech Pharmacal Co., Inc., Approval | Neurontin (gabapentin) Capsules, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) Oral Solution, Pfizer Inc., Labeling Revision | Neurontin (gabapentin) Tablets, Pfizer Inc., Labeling Revision | Horizant (gabapentin enacarbil) Extended-Release Tablets, GlaxoSmithKline, Approval | Gralise (gabapentin) Tablets, Depomed, Inc., Supplement | Gralise (gabapentin) Tablets, Depomed, Inc., Labeling Revision | Gabapentin Capsules, Pharmgen LLC, Approval | Gabapentin Tablets, West-Ward Pharmaceutical Corp., Approval | Neurontin (gabapentin) Capsules, Pfizer, Inc., Labeling Revision | Neurontin (gabapentin) Tablets, Pfizer, Inc., Labeling Revision | Neurontin (gabapentin) Oral Solution, Pfizer, Inc., Labeling Revision | Gabapentin Tablets, Aurobindo Pharma Ltd., Approval
  
|