Product NDC: | 0037-0442 |
Proprietary Name: | Felbatol |
Non Proprietary Name: | felbamate |
Active Ingredient(s): | 600 mg/5mL & nbsp; felbamate |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0037-0442 |
Labeler Name: | Meda Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020189 |
Marketing Category: | NDA |
Start Marketing Date: | 19930729 |
Package NDC: | 0037-0442-67 |
Package Description: | 237 mL in 1 BOTTLE, PLASTIC (0037-0442-67) |
NDC Code | 0037-0442-67 |
Proprietary Name | Felbatol |
Package Description | 237 mL in 1 BOTTLE, PLASTIC (0037-0442-67) |
Product NDC | 0037-0442 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | felbamate |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 19930729 |
Marketing Category Name | NDA |
Labeler Name | Meda Pharmaceuticals Inc. |
Substance Name | FELBAMATE |
Strength Number | 600 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |