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Serving leading biopharmaceutical companies globally:

Farmers Insurance
US Army
Chinese Patent Office

Generated: November 23, 2017

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Details for New Drug Application (NDA): 089953

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

The generic ingredient in THIORIDAZINE HYDROCHLORIDE is thioridazine hydrochloride. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the thioridazine hydrochloride profile page.

Summary for 089953

Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

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
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
TABLET;ORAL 089953 ANDA Sun Pharmaceutical Industries, Inc. 53489-148 53489-148-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-148-10)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
US Department of Justice
Express Scripts
Federal Trade Commission
Daiichi Sankyo
Chinese Patent Office

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