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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 Teva Pharms, 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, and Alpharma Us Pharms, 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

thioridazine hydrochloride
Therapeutic Class:Antipsychotics

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
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
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:Yes

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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