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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 089743


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NDA 089743 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Pharm Assoc, Fresenius Kabi Usa, Ajanta Pharma Ltd, Amneal, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, and Zydus, and is included in twenty-seven NDAs. It is available from twenty-eight suppliers. Additional details are available on the FLUPHENAZINE HYDROCHLORIDE profile page.

The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are nineteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 089743
Tradename:FLUPHENAZINE HYDROCHLORIDE
Applicant:Lannett Co Inc
Ingredient:fluphenazine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 089743
Suppliers and Packaging for NDA: 089743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089743 ANDA Lannett Company, Inc. 0527-1788 0527-1788-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1788-01)
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089743 ANDA Lannett Company, Inc. 0527-1788 0527-1788-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1788-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 25, 1988TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 1988TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 25, 1988TE:ABRLD:No

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