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Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074531

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NDA 074531 describes FLUPHENAZINE DECANOATE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, Par Sterile Products, Teva Parenteral, and West-ward Pharms Int, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the FLUPHENAZINE DECANOATE profile page.

The generic ingredient in FLUPHENAZINE DECANOATE is fluphenazine decanoate. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fluphenazine decanoate profile page.
Summary for 074531
Applicant:West-ward Pharms Int
Ingredient:fluphenazine decanoate
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
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 West-Ward Pharmaceuticals Corp 0143-9529 N 0143-9529-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Aug 30, 1996TE:AORLD:No

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