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Last Updated: August 4, 2020

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FLUPHENAZINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for fluphenazine hydrochloride and what is the scope of freedom to operate?

Fluphenazine hydrochloride is the generic ingredient in three branded drugs marketed by Ani Pharms Inc, Pharm Assoc, Schering, Apothecon, Fresenius Kabi Usa, Lannett Co Inc, Mylan, Sandoz, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for fluphenazine hydrochloride. Eight suppliers are listed for this compound.

Recent Clinical Trials for FLUPHENAZINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Canadian Institutes of Health Research (CIHR)N/A
Drug Safety and Effectiveness Network, CanadaN/A
Canadian Network for Observational Drug Effect Studies, CNODESN/A

See all FLUPHENAZINE HYDROCHLORIDE clinical trials

Pharmacology for FLUPHENAZINE HYDROCHLORIDE
Drug ClassPhenothiazine

US Patents and Regulatory Information for FLUPHENAZINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Schering PERMITIL fluphenazine hydrochloride TABLET;ORAL 012034-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Schering PERMITIL fluphenazine hydrochloride TABLET;ORAL 012034-005 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089804-003 Aug 12, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Pharm Assoc FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride ELIXIR;ORAL 040146-001 Aug 21, 1996 RX No Yes   Start Trial   Start Trial   Start Trial
Sandoz FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089586-001 Oct 16, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride ELIXIR;ORAL 081310-001 Apr 29, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride CONCENTRATE;ORAL 073058-001 Aug 30, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Colorcon

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