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Cantor Fitzgerald
Fuji
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Queensland Health
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Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089804

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NDA 089804 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Pharm Assoc, Fresenius Kabi Usa, Lannett Co Inc, Mylan, Sandoz, and Watson Labs, and is included in twelve NDAs. It is available from twelve suppliers. Additional details are available on the FLUPHENAZINE HYDROCHLORIDE profile page.

The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 089804
Tradename:FLUPHENAZINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:fluphenazine hydrochloride
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 089804
Ingredient-typePhenothiazines
Suppliers and Packaging for NDA: 089804
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089804 ANDA Mylan Pharmaceuticals Inc. 0378-6004 N 0378-6004-01
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089804 ANDA Mylan Pharmaceuticals Inc. 0378-6004 N 0378-6004-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 12, 1988TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 12, 1988TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 12, 1988TE:ABRLD:No

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