Orange Book product · Brand (NDA)
XENAZINE
TETRABENAZINE
At a glance
Aug 15, 2008
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 15, 2008
18 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
TETRABENAZINE
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021894
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020TETRABENAZINEGeneric (ANDA)
ANDA 213621 · AJANTA PHARMA LTD
- 2020TETRABENAZINEGeneric (ANDA)
ANDA 206093 · APOTEX
- 2020TETRABENAZINEGeneric (ANDA)
ANDA 213316 · ADAPTIS
- 2019TETRABENAZINEGeneric (ANDA)
ANDA 209739 · HIKMA
- 2018TETRABENAZINEGeneric (ANDA)
ANDA 210544 · CHARTWELL RX
- 2018TETRABENAZINEGeneric (ANDA)
ANDA 209284 · DR REDDYS
- 2017TETRABENAZINEGeneric (ANDA)
ANDA 208826 · BIONPHARMA
- 2017TETRABENAZINEGeneric (ANDA)
ANDA 206686 · ACTAVIS LABS FL INC
- 2017TETRABENAZINEGeneric (ANDA)
ANDA 207682 · MYLAN
- 2016TETRABENAZINEGeneric (ANDA)
ANDA 204574 · HETERO LABS LTD V
- 2015TETRABENAZINEGeneric (ANDA)
ANDA 206129 · SUN PHARM
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
