Orange Book product · Brand (NDA)
NAVANE
THIOTHIXENE 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
THIOTHIXENE HYDROCHLORIDE
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CONCENTRATE
Route
ORAL
TE code
Not listed
Application
NDA 016758
Product number
001
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.
- —NAVANEBrand (NDA)
NDA 016904 · PFIZER
- 1992THIOTHIXENE HYDROCHLORIDE INTENSOLGeneric (ANDA)
ANDA 073494 · HIKMA
- 1989THIOTHIXENE HYDROCHLORIDEGeneric (ANDA)
ANDA 071917 · PACO
- 1988THIOTHIXENE HYDROCHLORIDEGeneric (ANDA)
ANDA 071939 · PACO
- 1987THIOTHIXENE HYDROCHLORIDEGeneric (ANDA)
ANDA 070969 · ALPHARMA US PHARMS
- 1987THIOTHIXENE HYDROCHLORIDEGeneric (ANDA)
ANDA 071554 · TEVA PHARMS
- 1987THIOTHIXENE HYDROCHLORIDEGeneric (ANDA)
ANDA 071184 · TEVA
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.
