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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Daiichi Sankyo
Fish and Richardson
US Army

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075393

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NDA 075393 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.

The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 075393
Applicant:Teva Pharms Usa
Ingredient:haloperidol decanoate
Formulation / Manufacturing:see details
Pharmacology for NDA: 075393
Suppliers and Packaging for NDA: 075393
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075393 ANDA Teva Parenteral Medicines, Inc. 0703-7011 0703-7011-03 10 VIAL, SINGLE-DOSE in 1 CARTON (0703-7011-03) > 1 mL in 1 VIAL, SINGLE-DOSE (0703-7011-01)
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075393 ANDA Teva Parenteral Medicines, Inc. 0703-7013 0703-7013-01 1 VIAL, MULTI-DOSE in 1 CARTON (0703-7013-01) > 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:May 11, 1999TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:May 11, 1999TE:AORLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chinese Patent Office
Express Scripts

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