| Betterchem |

|
|
| FDA approval activities
for this prescription 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, Tentatively Approved 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, Tentatively Approved 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, Tentatively Approved 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 , Tentative Approval |
© 2007 Betterchem Corp.
|