Product NDC: | 0245-0708 |
Proprietary Name: | topiramate |
Non Proprietary Name: | topiramate |
Active Ingredient(s): | 50 mg/1 & nbsp; topiramate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0245-0708 |
Labeler Name: | Upsher-Smith Laboratories, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078499 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110502 |
Package NDC: | 0245-0708-60 |
Package Description: | 60 TABLET, COATED in 1 BOTTLE (0245-0708-60) |
NDC Code | 0245-0708-60 |
Proprietary Name | topiramate |
Package Description | 60 TABLET, COATED in 1 BOTTLE (0245-0708-60) |
Product NDC | 0245-0708 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | topiramate |
Dosage Form Name | TABLET, COATED |
Route Name | ORAL |
Start Marketing Date | 20110502 |
Marketing Category Name | ANDA |
Labeler Name | Upsher-Smith Laboratories, 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] |