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Last Updated: June 14, 2021

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Details for New Drug Application (NDA): 076463


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NDA 076463 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Labs Ltd, Sandoz Inc, Somerset Theraps Llc, Teva Pharms Usa, West-ward Pharms Int, and Zydus Pharms, and is included in ten NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 076463
Tradename:HALOPERIDOL DECANOATE
Applicant:Sandoz Inc
Ingredient:haloperidol decanoate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Jun 24, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Jun 24, 2005TE:RLD:No

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