Product NDC: | 17772-122 |
Proprietary Name: | OXTELLAR XR |
Non Proprietary Name: | OXCARBAZEPINE |
Active Ingredient(s): | 300 mg/1 & nbsp; OXCARBAZEPINE |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 17772-122 |
Labeler Name: | Supernus |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA202810 |
Marketing Category: | NDA |
Start Marketing Date: | 20130117 |
Package NDC: | 17772-122-01 |
Package Description: | 100 TABLET in 1 BOTTLE (17772-122-01) |
NDC Code | 17772-122-01 |
Proprietary Name | OXTELLAR XR |
Package Description | 100 TABLET in 1 BOTTLE (17772-122-01) |
Product NDC | 17772-122 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | OXCARBAZEPINE |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20130117 |
Marketing Category Name | NDA |
Labeler Name | Supernus |
Substance Name | OXCARBAZEPINE |
Strength Number | 300 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |