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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203732

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NDA 203732 describes FLUPHENAZINE DECANOATE, which is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, MSN, Mylan Labs Ltd, Ph Health, and Teva Parenteral, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the FLUPHENAZINE DECANOATE profile page.

The generic ingredient in FLUPHENAZINE DECANOATE is fluphenazine decanoate. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluphenazine decanoate profile page.

Summary for 203732

Tradename:	FLUPHENAZINE DECANOATE
Applicant:	Ph Health
Ingredient:	fluphenazine decanoate
Patents:	0

Pharmacology for NDA: 203732

Suppliers and Packaging for NDA: 203732

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	203732	ANDA	Endo USA, Inc.	42023-129	42023-129-01	1 VIAL in 1 CARTON (42023-129-01) / 5 mL in 1 VIAL
FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	203732	ANDA	Endo USA, Inc.	42023-129	42023-129-89	1 VIAL in 1 CARTON (42023-129-89) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Jul 3, 2014	TE:	AO	RLD:	No

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