Onfi - 67386-313-21 - (clobazam)

Alphabetical Index


Drug Information of Onfi

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)

Labeler Information of Onfi

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 Information of Onfi

Package NDC: 67386-313-21
Package Description: 1 BOTTLE in 1 CARTON (67386-313-21) > 120 mL in 1 BOTTLE

NDC Information of Onfi

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]

Complete Information of Onfi


General Information