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Last Updated: March 18, 2026

Details for New Drug Application (NDA): 012145

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NDA 012145 describes PROLIXIN, which is a drug marketed by Apothecon and Bristol Myers Squibb and is included in five NDAs. Additional details are available on the PROLIXIN profile page.

The generic ingredient in PROLIXIN is fluphenazine enanthate. There are nineteen drug master file entries for this compound. Additional details are available on the fluphenazine enanthate profile page.

Summary for 012145

Tradename:	PROLIXIN
Applicant:	Apothecon
Ingredient:	fluphenazine hydrochloride
Patents:	0

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	ELIXIR;ORAL			Strength	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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