Product NDC: | 52959-994 |
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: | 52959-994 |
Labeler Name: | H.J. Harkins Company, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA079153 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090327 |
Package NDC: | 52959-994-60 |
Package Description: | 60 TABLET in 1 BOTTLE (52959-994-60) |
NDC Code | 52959-994-60 |
Proprietary Name | TOPIRAMATE |
Package Description | 60 TABLET in 1 BOTTLE (52959-994-60) |
Product NDC | 52959-994 |
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 | H.J. Harkins Company, Inc. |
Substance Name | TOPIRAMATE |
Strength Number | 50 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |