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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Dow
Novartis
Queensland Health
Boehringer Ingelheim
Fuji
QuintilesIMS
Fish and Richardson
Merck
Daiichi Sankyo
Baxter

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076774

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NDA 076774 describes HALOPERIDOL, which is a drug marketed by Alpharma, Morton Grove, Pharm Assoc, SCS, Silarx, Teva, Teva Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, 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, and Actavis Mid Atlantic, and is included in one hundred and six NDAs. It is available from thirty-seven 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 076774

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076774

Suppliers and Packaging for NDA: 076774

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 076774 ANDA Breckenridge Pharmaceutical, Inc. 51991-933 51991-933-17 10 SYRINGE in 1 BOX (51991-933-17) > 1 mL in 1 SYRINGE (51991-933-99)
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 076774 ANDA Gland Pharma Limited 68083-117 68083-117-01 10 SYRINGE in 1 BOX (68083-117-01) > 1 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Aug 25, 2004TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Novartis
Baxter
Boehringer Ingelheim
US Department of Justice
US Army
Colorcon
Johnson and Johnson
Fish and Richardson
Cipla
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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