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Generated: June 26, 2019

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Details for New Drug Application (NDA): 088004

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NDA 088004 describes THIORIDAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Ani Pharms Inc, Hi Tech Pharma, Pharm Assoc, Sandoz, Wockhardt, Fosun Pharma, Heritage Pharma, 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 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 088004
Tradename:THIORIDAZINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:thioridazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 088004
Suppliers and Packaging for NDA: 088004
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 088004 ANDA Mylan Pharmaceuticals Inc. 0378-0612 0378-0612-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0612-01)
THIORIDAZINE HYDROCHLORIDE thioridazine hydrochloride TABLET;ORAL 088004 ANDA Mylan Pharmaceuticals Inc. 0378-0614 0378-0614-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0614-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Nov 18, 1983TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Mar 15, 1983TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Mar 15, 1983TE:ABRLD:No

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