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Generated: November 17, 2018

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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, SCS, Teva, Teva Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, Anda Repository, Cycle Pharms Ltd, Duramed Pharms Barr, Lederle, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sandoz, Vintage, Zydus Pharms Usa, Hospira, Sandoz Inc, Somerset Theraps Llc, and Actavis Mid Atlantic, and is included in one hundred and seven NDAs. It is available from thirty-six 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. Nine 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 General Injectables and Vaccines, Inc 52584-474 52584-474-01 1 VIAL in 1 BAG (52584-474-01) > 1 mL in 1 VIAL
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 075689 ANDA Cardinal Health 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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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
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Fish and Richardson
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Deloitte
Boehringer Ingelheim
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Dow

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