Orange Book product · Brand (NDA)
STELAZINE
TRIFLUOPERAZINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Strength
EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 011552
Product number
005
Marketing status
DISCN
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.
- 1997TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040209 · MYLAN
- 1996TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040153 · POM PHARMA
- 1988TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 085975 · WATSON LABS
- 1988TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 085976 · WATSON LABS
- 1988TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 085973 · WATSON LABS
- 1988TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088710 · WATSON LABS
- 1985TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088967 · DURAMED PHARMS BARR
- 1985TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088968 · DURAMED PHARMS BARR
- 1985TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088969 · DURAMED PHARMS BARR
- 1985TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088970 · DURAMED PHARMS BARR
- 1983TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088143 · WOCKHARDT
- 1982TRIFLUOPERAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 087612 · IVAX PHARMS
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.
