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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 075689


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NDA 075689 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, SCS, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, Actavis Group, Aiping Pharm Inc, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sciegen Pharms Inc, Strides Pharma, Upsher Smith Labs, Zydus Pharms Usa, Hospira, Mankind Pharma, Meitheal, Sandoz, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic, and is included in one hundred and seven NDAs. It is available from thirty-one suppliers. Additional details are available on the HALOPERIDOL profile page.

The generic ingredient in HALOPERIDOL 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 075689
Tradename:HALOPERIDOL
Applicant:Fresenius Kabi Usa
Ingredient:haloperidol lactate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075689
Suppliers and Packaging for NDA: 075689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 075689 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1524 51662-1524-1 1 mL in 1 VIAL (51662-1524-1)
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 075689 ANDA Cardinal Health 107, LLC 55154-9553 55154-9553-5 5 VIAL in 1 BAG (55154-9553-5) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Mar 9, 2001TE:APRLD:No

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