Product NDC: | 0078-0357 |
Proprietary Name: | Trileptal |
Non Proprietary Name: | oxcarbazepine |
Active Ingredient(s): | 60 mg/mL & nbsp; oxcarbazepine |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0357 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021285 |
Marketing Category: | NDA |
Start Marketing Date: | 20010530 |
Package NDC: | 0078-0357-52 |
Package Description: | 250 mL in 1 BOTTLE (0078-0357-52) |
NDC Code | 0078-0357-52 |
Proprietary Name | Trileptal |
Package Description | 250 mL in 1 BOTTLE (0078-0357-52) |
Product NDC | 0078-0357 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | oxcarbazepine |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20010530 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | OXCARBAZEPINE |
Strength Number | 60 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |