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Last Updated: August 5, 2021

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Details for New Drug Application (NDA): 074893


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NDA 074893 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 074893
Tradename:HALOPERIDOL DECANOATE
Applicant:Fresenius Kabi Usa
Ingredient:haloperidol decanoate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074893
Suppliers and Packaging for NDA: 074893
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 074893 ANDA Fresenius Kabi USA, LLC 63323-469 63323-469-01 1 VIAL in 1 CARTON (63323-469-01) > 1 mL in 1 VIAL
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 074893 ANDA Fresenius Kabi USA, LLC 63323-469 63323-469-05 1 VIAL, MULTI-DOSE in 1 CARTON (63323-469-05) > 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Dec 19, 1997TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Dec 19, 1997TE:AORLD:No

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