| Product NDC: | 16590-825 |
| Proprietary Name: | TOPIRAMATE |
| Non Proprietary Name: | TOPIRAMATE |
| Active Ingredient(s): | 50 mg/1 & nbsp; TOPIRAMATE |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-825 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA079153 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090327 |
| Package NDC: | 16590-825-90 |
| Package Description: | 90 TABLET in 1 BOTTLE, PLASTIC (16590-825-90) |
| NDC Code | 16590-825-90 |
| Proprietary Name | TOPIRAMATE |
| Package Description | 90 TABLET in 1 BOTTLE, PLASTIC (16590-825-90) |
| Product NDC | 16590-825 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | TOPIRAMATE |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090327 |
| Marketing Category Name | ANDA |
| Labeler Name | STAT Rx USA LLC |
| Substance Name | TOPIRAMATE |
| Strength Number | 50 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |