Orange Book product · Brand (NDA)
MELLARIL
THIORIDAZINE 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
THIORIDAZINE HYDROCHLORIDE
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 011808
Product number
003
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.
- 1998THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040213 · PHARM ASSOC
- 1997THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040187 · PHARM ASSOC
- 1996THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040125 · EPIC PHARMA LLC
- 1996THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040126 · EPIC PHARMA LLC
- 1988THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089764 · PAR PHARM
- 1988THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089765 · PAR PHARM
- 1987THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089602 · ANI PHARMS
- 1987THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 089603 · ANI PHARMS
- 1986THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088136 · CHARTWELL RX
- 1986THIORIDAZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 088137 · CHARTWELL RX
- 1985THIORIDAZINE HYDROCHLORIDE INTENSOLGeneric (ANDA)
ANDA 088941 · ROXANE
- 1985THIORIDAZINE HYDROCHLORIDE INTENSOLGeneric (ANDA)
ANDA 088942 · ROXANE
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.
