FDA Orange Book · active-ingredient family
Trifluoperazine hydrochloride
Trifluoperazine hydrochloride is approved as 1 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:STELAZINE · NDA 011552
1
Brand (NDA)
20
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · concentrate, injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| STELAZINERLD×6 | GLAXOSMITHKLINE | NDA 011552 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (20)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIFLUOPERAZINE HYDROCHLORIDE×4 | MYLAN | ANDA 040209 | AB | Jul 07, 1997 | |
| TRIFLUOPERAZINE HYDROCHLORIDE×4 | POM PHARMA | ANDA 040153 | — | Oct 25, 1996 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | WATSON LABS | ANDA 085975 | — | Jun 23, 1988 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | WATSON LABS | ANDA 085976 | — | Jun 23, 1988 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | WATSON LABS | ANDA 085973 | — | Jun 23, 1988 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | WATSON LABS | ANDA 088710 | — | Jun 23, 1988 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | DURAMED PHARMS BARR | ANDA 088967 | — | Apr 23, 1985 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | DURAMED PHARMS BARR | ANDA 088968 | — | Apr 23, 1985 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | DURAMED PHARMS BARR | ANDA 088969 | — | Apr 23, 1985 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | DURAMED PHARMS BARR | ANDA 088970 | — | Apr 23, 1985 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | WOCKHARDT | ANDA 088143 | — | Jul 26, 1983 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | IVAX PHARMS | ANDA 087612 | — | Nov 19, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | IVAX PHARMS | ANDA 087613 | — | Nov 19, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | IVAX PHARMS | ANDA 087328 | — | Nov 19, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | IVAX PHARMS | ANDA 087614 | — | Nov 19, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | CHARTWELL RX | ANDA 085787 | — | Apr 15, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | SANDOZ | ANDA 085785 | AB | Approved Prior to Jan 1, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | SANDOZ | ANDA 085786 | AB | Approved Prior to Jan 1, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | SANDOZ | ANDA 085789 | AB | Approved Prior to Jan 1, 1982 | |
| TRIFLUOPERAZINE HYDROCHLORIDE | SANDOZ | ANDA 085788 | AB | Approved Prior to Jan 1, 1982 |
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.
Trifluoperazine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
