Details for New Drug Application (NDA): 021894
✉ Email this page to a colleague
NDA 021894 describes XENAZINE, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the XENAZINE profile page.
The generic ingredient in XENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
The generic ingredient in XENAZINE is tetrabenazine. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the tetrabenazine profile page.
Summary for 021894
| Tradename: | XENAZINE |
| Applicant: | Bausch |
| Ingredient: | tetrabenazine |
| Patents: | 0 |
Pharmacology for NDA: 021894
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 021894
Suppliers and Packaging for NDA: 021894
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA | Lundbeck Pharmaceuticals LLC | 67386-421 | 67386-421-01 | 112 TABLET in 1 BOTTLE (67386-421-01) |
| XENAZINE | tetrabenazine | TABLET;ORAL | 021894 | NDA | Lundbeck Pharmaceuticals LLC | 67386-422 | 67386-422-01 | 112 TABLET in 1 BOTTLE (67386-422-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Aug 15, 2008 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Aug 15, 2008 | TE: | AB | RLD: | Yes | ||||
Complete Access Available with Subscription
