Product NDC: | 0054-0199 |
Proprietary Name: | Oxcarbazepine |
Non Proprietary Name: | Oxcarbazepine |
Active Ingredient(s): | 300 mg/5mL & nbsp; Oxcarbazepine |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0054-0199 |
Labeler Name: | Roxane Laboratories, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA201193 |
Marketing Category: | ANDA |
Start Marketing Date: | 20121003 |
Package NDC: | 0054-0199-59 |
Package Description: | 250 mL in 1 BOTTLE (0054-0199-59) |
NDC Code | 0054-0199-59 |
Proprietary Name | Oxcarbazepine |
Package Description | 250 mL in 1 BOTTLE (0054-0199-59) |
Product NDC | 0054-0199 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Oxcarbazepine |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20121003 |
Marketing Category Name | ANDA |
Labeler Name | Roxane Laboratories, Inc |
Substance Name | OXCARBAZEPINE |
Strength Number | 300 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |