Last Updated: September 28, 2026

Details for New Drug Application (NDA): 089953


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NDA 089953 describes THIORIDAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Ani Pharms, Epic Pharma Llc, Pharm Assoc, Sandoz, Wockhardt, Chartwell Rx, Heritage Pharma Avet, Mutual Pharm, Mylan, Par Pharm, Roxane, Sun Pharm Industries, Superpharm, Watson Labs, Watson Labs Teva, and West Ward, and is included in seventy-nine NDAs. It is available from five suppliers. Additional details are available on the THIORIDAZINE HYDROCHLORIDE profile page.

The generic ingredient in THIORIDAZINE HYDROCHLORIDE is thioridazine hydrochloride. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the thioridazine hydrochloride profile page.
Summary for 089953
Tradename:THIORIDAZINE HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:thioridazine hydrochloride
Patents:0
Pharmacology for NDA: 089953
Suppliers and Packaging for NDA: 089953
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 089953 ANDA Sun Pharmaceutical Industries, Inc. 53489-148 53489-148-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-148-01)
THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 089953 ANDA Sun Pharmaceutical Industries, Inc. 53489-148 53489-148-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-148-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Oct 7, 1988TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Aug 1, 1986TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength25MG
Approval Date:Aug 1, 1986TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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