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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074531

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NDA 074531 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 074531

Tradename:	FLUPHENAZINE DECANOATE
Applicant:	Hikma
Ingredient:	fluphenazine decanoate
Patents:	0

Pharmacology for NDA: 074531

Suppliers and Packaging for NDA: 074531

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074531	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9529	0143-9529-01	1 VIAL, MULTI-DOSE in 1 BOX (0143-9529-01) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	25MG/ML
Approval Date:	Aug 30, 1996	TE:	AO	RLD:	No

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