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MELLARIL

NDA

THIORIDAZINE HYDROCHLORIDE | N011808 | NOVARTIS PHARMACEUTICALS CORP

9 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF5 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TRIFARMA SPATHIORIDAZINE HYDROCHLORIDE

DMF 41201981

ORION CORP LTDInactiveTHIORIDAZINE HYDROCHLORIDE

DMF 46081982

SELOC AGInactiveTHIORIDAZINE HYDROCHLORIDE

DMF 59991985

GANES CHEMICALS INC PENNSVILLE DIVInactiveTHIORIDAZINE HYDROCHLORIDE

DMF 61211985

INTERMEDI CHIMICI SINTETICI SPA ZONA INDUSTRIALEInactiveTHIORIDAZINE HYDROCHLORIDE USP

DMF 63221986

HEXAGON LABORATORIES INCInactiveTHIORIDAZINE HYDROCHLORIDE

DMF 64721985

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 15, 2001	SUPPL -178	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (9)

Sort:

#003 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#006 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#009 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#011 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#012 — 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

CONCENTRATE;ORAL | Approved: Approved Prior to Jan 1, 1982

#015 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#016 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#017 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#018 — 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

CONCENTRATE;ORAL | Approved: Approved Prior to Jan 1, 1982