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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Queensland Health
Harvard Business School

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091637

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NDA 091637 describes HALOPERIDOL, which is a drug marketed by Alpharma, Morton Grove, Pharm Assoc, SCS, Silarx, 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, and Actavis Mid Atlantic, and is included in one hundred and six NDAs. It is available from thirty-eight 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. Eight suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 091637
Applicant:Sagent Pharms
Ingredient:haloperidol lactate
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Pharmacology for NDA: 091637
Suppliers and Packaging for NDA: 091637
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 091637 ANDA Sagent Pharmaceuticals 25021-806 N 25021-806-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Sep 2, 2011TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Department of Justice
US Army
Johnson and Johnson

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