Last Updated: September 24, 2026

Details for New Drug Application (NDA): 071413

✉ Email this page to a colleague

« Back to Dashboard

NDA 071413 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 nine suppliers. Additional details are available on the FLUPHENAZINE DECANOATE profile page.

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

Summary for 071413

Tradename:	FLUPHENAZINE DECANOATE
Applicant:	Fresenius Kabi Usa
Ingredient:	fluphenazine decanoate
Patents:	0

Pharmacology for NDA: 071413

Suppliers and Packaging for NDA: 071413

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	071413	ANDA	Fresenius Kabi USA, LLC	63323-272	63323-272-05	1 VIAL, MULTI-DOSE in 1 CARTON (63323-272-05) / 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:	Jul 14, 1987	TE:	AO	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.