Details for New Drug Application (NDA): 203993
✉ Email this page to a colleague
NDA 203993 describes ONFI, which is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the ONFI profile page.
The generic ingredient in ONFI is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.
The generic ingredient in ONFI is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 203993
| Tradename: | ONFI |
| Applicant: | Lundbeck Pharms Llc |
| Ingredient: | clobazam |
| Patents: | 0 |
Pharmacology for NDA: 203993
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Suppliers and Packaging for NDA: 203993
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONFI | clobazam | SUSPENSION;ORAL | 203993 | NDA | Lundbeck Pharmaceuticals LLC | 67386-313 | 67386-313-21 | 1 BOTTLE in 1 CARTON (67386-313-21) / 120 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 2.5MG/ML | ||||
| Approval Date: | Dec 14, 2012 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
