FDA Orange Book · active-ingredient family
Tetrabenazine
Tetrabenazine is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XENAZINE · NDA 021894
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XENAZINERLD×2 | BAUSCH | NDA 021894 | AB | Aug 15, 2008 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TETRABENAZINE×2 | AJANTA PHARMA LTD | ANDA 213621 | — | Dec 04, 2020 | |
| TETRABENAZINE×2 | APOTEX | ANDA 206093 | AB | Mar 17, 2020 | |
| TETRABENAZINE×2 | ADAPTIS | ANDA 213316 | AB | Jan 22, 2020 | |
| TETRABENAZINE×2 | HIKMA | ANDA 209739 | — | Apr 08, 2019 | |
| TETRABENAZINE×2 | CHARTWELL RX | ANDA 210544 | AB | Apr 20, 2018 | |
| TETRABENAZINE×2 | DR REDDYS | ANDA 209284 | AB | Jan 08, 2018 | |
| TETRABENAZINE×2 | BIONPHARMA | ANDA 208826 | AB | Dec 18, 2017 | |
| TETRABENAZINE | ACTAVIS LABS FL INC | ANDA 206686 | AB | Jul 07, 2017 | |
| TETRABENAZINE×2 | MYLAN | ANDA 207682 | AB | Jan 31, 2017 | |
| TETRABENAZINE×2 | HETERO LABS LTD V | ANDA 204574 | AB | Feb 03, 2016 | |
| TETRABENAZINE×2 | SUN PHARM | ANDA 206129 | — | Aug 17, 2015 |
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.
Tetrabenazine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
