Product NDC: | 0904-6016 |
Proprietary Name: | Topiramate |
Non Proprietary Name: | topiramate |
Active Ingredient(s): | 25 mg/1 & nbsp; topiramate |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0904-6016 |
Labeler Name: | Major Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076311 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090610 |
Package NDC: | 0904-6016-04 |
Package Description: | 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6016-04) |
NDC Code | 0904-6016-04 |
Proprietary Name | Topiramate |
Package Description | 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0904-6016-04) |
Product NDC | 0904-6016 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | topiramate |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20090610 |
Marketing Category Name | ANDA |
Labeler Name | Major Pharmaceuticals |
Substance Name | TOPIRAMATE |
Strength Number | 25 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |