Details for New Drug Application (NDA): 204574
✉ Email this page to a colleague
NDA 204574 describes TETRABENAZINE, which is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, Slate Run Pharma, and Sun Pharm, and is included in eleven NDAs. It is available from ten suppliers. Additional details are available on the TETRABENAZINE profile page.
The generic ingredient in TETRABENAZINE 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 TETRABENAZINE 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 204574
| Tradename: | TETRABENAZINE |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | tetrabenazine |
| Patents: | 0 |
Pharmacology for NDA: 204574
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Medical Subject Heading (MeSH) Categories for 204574
Suppliers and Packaging for NDA: 204574
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TETRABENAZINE | tetrabenazine | TABLET;ORAL | 204574 | ANDA | Camber Pharmaceuticals, Inc. | 31722-821 | 31722-821-11 | 112 TABLET, COATED in 1 BOTTLE (31722-821-11) |
| TETRABENAZINE | tetrabenazine | TABLET;ORAL | 204574 | ANDA | Camber Pharmaceuticals, Inc. | 31722-821 | 31722-821-31 | 10 TABLET, COATED in 1 BLISTER PACK (31722-821-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Feb 3, 2016 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 3, 2016 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
