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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088004

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NDA 088004 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 NDA: 088004

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 088004

Ingredient-typePhenothiazines

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Merck
US Department of Justice
Chubb
UBS
Medtronic
Harvard Business School
Federal Trade Commission
Johnson and Johnson
Mallinckrodt
Express Scripts

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