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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214507


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NDA 214507 describes HALOPERIDOL DECANOATE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in twelve NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 214507
Tradename:HALOPERIDOL DECANOATE
Applicant:Meitheal
Ingredient:haloperidol decanoate
Patents:0
Pharmacology for NDA: 214507
Suppliers and Packaging for NDA: 214507
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 214507 ANDA REMEDYREPACK INC. 70518-3743 70518-3743-0 10 VIAL, SINGLE-DOSE in 1 CARTON (70518-3743-0) / 1 mL in 1 VIAL, SINGLE-DOSE (70518-3743-1)
HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 214507 ANDA Meitheal Pharmaceuticals Inc. 71288-502 71288-502-02 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-502-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-502-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Jul 26, 2021TE:AORLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Jul 26, 2021TE:AORLD:No

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