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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, Pharm Assoc, Schering, Apothecon, Fresenius Kabi Usa, Amneal, Cerovene Inc, Lannett Co Inc, Mylan, Novitium Pharma, Sandoz, Watson Labs, and Zydus, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for fluphenazine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	22
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	9
Patent Applications:	2,489
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in fluphenazine hydrochloride?	fluphenazine hydrochloride excipients list
DailyMed Link:	fluphenazine hydrochloride at DailyMed

Recent Clinical Trials for fluphenazine hydrochloride

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

Sponsor	Phase
Drug Safety and Effectiveness Network, Canada	N/A
Canadian Network for Observational Drug Effect Studies, CNODES	N/A
Canadian Institutes of Health Research (CIHR)	N/A

See all fluphenazine hydrochloride clinical trials

Pharmacology for fluphenazine hydrochloride

Drug Class

Phenothiazine

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
Cerovene Inc	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	214534-001	Jan 7, 2021	AB	RX	No	No
Apothecon	PROLIXIN	fluphenazine hydrochloride	TABLET;ORAL	011751-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Zydus	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	214552-002	May 27, 2021	AB	RX	No	No
Amneal	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	213647-002	Jul 9, 2020	AB	RX	No	No
Apothecon	PROLIXIN	fluphenazine hydrochloride	ELIXIR;ORAL	012145-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Schering	PERMITIL	fluphenazine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	012419-004	Approved Prior to Jan 1, 1982		DISCN	No	No