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Details for New Drug Application (NDA): 085789

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NDA 085789 describes TRIFLUOPERAZINE HYDROCHLORIDE, which is a drug marketed by Mylan, Watson Labs, Ivax Pharms, Wockhardt, Sandoz, and Duramed Pharms Barr, and is included in twenty NDAs. It is available from eight suppliers. Additional details are available on the TRIFLUOPERAZINE HYDROCHLORIDE profile page.

The generic ingredient in TRIFLUOPERAZINE HYDROCHLORIDE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.

Summary for NDA: 085789

trifluoperazine hydrochloride
Therapeutic Class:Antipsychotics

Pharmacology for NDA: 085789


Suppliers and Packaging for NDA: 085789

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
trifluoperazine hydrochloride
TABLET;ORAL 085789 ANDA Sandoz Inc 0781-1034 0781-1034-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1034-01)
trifluoperazine hydrochloride
TABLET;ORAL 085789 ANDA Sandoz Inc 0781-1034 0781-1034-05 500 TABLET, FILM COATED in 1 BOTTLE (0781-1034-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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