Orange Book product · Generic (ANDA)
TETRABENAZINE
TETRABENAZINE
At a glance
Jan 22, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 22, 2020
6 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
TETRABENAZINE
Strength
12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213316
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TETRABENAZINE
- 2008XENAZINEBrand (NDA)
NDA 021894 · BAUSCH
- 2020TETRABENAZINEGeneric (ANDA)
ANDA 213621 · AJANTA PHARMA LTD
- 2020TETRABENAZINEGeneric (ANDA)
ANDA 206093 · APOTEX
- 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.
