Product NDC: | 67386-313 |
Proprietary Name: | Onfi |
Non Proprietary Name: | clobazam |
Active Ingredient(s): | 2.5 mg/mL & nbsp; clobazam |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 67386-313 |
Labeler Name: | Lundbeck LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA203993 |
Marketing Category: | NDA |
Start Marketing Date: | 20121214 |
Package NDC: | 67386-313-21 |
Package Description: | 1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE |
NDC Code | 67386-313-21 |
Proprietary Name | Onfi |
Package Description | 1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE |
Product NDC | 67386-313 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | clobazam |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20121214 |
Marketing Category Name | NDA |
Labeler Name | Lundbeck LLC |
Substance Name | CLOBAZAM |
Strength Number | 2.5 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Benzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient],Cytochrome P450 2D6 Inhibitors [MoA] |