| 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] |