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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Queensland Health
US Department of Justice
Federal Trade Commission

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203732

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NDA 203732 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 203732
Applicant:Par Sterile Products
Ingredient:fluphenazine decanoate
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
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 Par Pharmaceutical, Inc. 42023-129 N 42023-129-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Jul 3, 2014TE:AORLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Argus Health

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