FDA Orange Book · active-ingredient family
Thiothixene
Thiothixene is approved as 1 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NAVANE · NDA 016584
1
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAVANERLD×5 | PFIZER | NDA 016584 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| THIOTHIXENE×4 | AMNEAL | ANDA 215456 | AB | Feb 28, 2022 | |
| THIOTHIXENE×4 | NOVITIUM PHARMA | ANDA 211642 | AB | Apr 05, 2019 | |
| THIOTHIXENE | AM THERAP | ANDA 072200 | — | Dec 17, 1987 | |
| THIOTHIXENE | AM THERAP | ANDA 071884 | — | Aug 12, 1987 | |
| THIOTHIXENE | AM THERAP | ANDA 071885 | — | Aug 12, 1987 | |
| THIOTHIXENE | AM THERAP | ANDA 071886 | — | Aug 12, 1987 | |
| THIOTHIXENE | AM THERAP | ANDA 071887 | — | Aug 12, 1987 | |
| THIOTHIXENE | WATSON LABS | ANDA 071626 | — | Jun 25, 1987 | |
| THIOTHIXENE | WATSON LABS | ANDA 071627 | — | Jun 25, 1987 | |
| THIOTHIXENE | WATSON LABS | ANDA 071628 | — | Jun 25, 1987 | |
| THIOTHIXENE×4 | EPIC PHARMA LLC | ANDA 071529 | — | Jun 24, 1987 | |
| THIOTHIXENE×4 | RISING | ANDA 071093 | AB | Jun 23, 1987 | |
| THIOTHIXENE | CHARTWELL RX | ANDA 070600 | — | Jun 05, 1987 | |
| THIOTHIXENE | CHARTWELL RX | ANDA 070601 | — | Jun 05, 1987 | |
| THIOTHIXENE | CHARTWELL RX | ANDA 070602 | — | Jun 05, 1987 | |
| THIOTHIXENE | CHARTWELL RX | ANDA 070603 | — | Jun 05, 1987 |
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.
Thiothixene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
