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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215141


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NDA 215141 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Pharm Assoc, Fresenius Kabi Usa, Ajanta Pharma Ltd, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Breckenridge, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Rising, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, and Zydus Lifesciences, and is included in twenty-nine 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 215141
Tradename:FLUPHENAZINE HYDROCHLORIDE
Applicant:Chartwell Rx
Ingredient:fluphenazine hydrochloride
Patents:0
Pharmacology for NDA: 215141
Suppliers and Packaging for NDA: 215141
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 215141 ANDA Chartwell RX, LLC 62135-415 62135-415-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-415-90)
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 215141 ANDA Chartwell RX, LLC 62135-416 62135-416-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-416-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 20, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 20, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 20, 2021TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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