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, Ajanta Pharma Ltd, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, 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 thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for fluphenazine hydrochloride. Thirty-one suppliers are listed for this compound.

Summary for FLUPHENAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	25
NDAs:	35
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	12
Patent Applications:	2,679
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
Janssen Scientific Affairs, LLC
Technische Universität München	Phase 4
Hannover Medical School	Phase 3

See all FLUPHENAZINE HYDROCHLORIDE clinical trials

Pharmacology for FLUPHENAZINE HYDROCHLORIDE

Drug Class	Phenothiazine

Anatomical Therapeutic Chemical (ATC) Classes for FLUPHENAZINE HYDROCHLORIDE

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for FLUPHENAZINE HYDROCHLORIDE

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Glossary

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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, EXTENDED RELEASE;ORAL	012419-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	217094-002	Jan 22, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett Co Inc	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	089743-002	Aug 25, 1988	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	088550-001	Dec 18, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	216350-004	Nov 6, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	FLUPHENAZINE HYDROCHLORIDE	fluphenazine hydrochloride	TABLET;ORAL	214674-004	Mar 1, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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