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Serving leading biopharmaceutical companies globally:

Cipla
Colorcon
Covington
Johnson and Johnson
Express Scripts
Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission
QuintilesIMS
Fuji

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070278

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NDA 070278 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 070278
Tradename:HALOPERIDOL
Applicant:Mylan
Ingredient:haloperidol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070278
Medical Subject Heading (MeSH) Categories for 070278
Suppliers and Packaging for NDA: 070278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL haloperidol TABLET;ORAL 070278 ANDA Mylan Pharmaceuticals Inc. 0378-0214 0378-0214-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0214-10)
HALOPERIDOL haloperidol TABLET;ORAL 070278 ANDA Mylan Pharmaceuticals Inc. 0378-0214 0378-0214-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0214-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jun 10, 1986TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 16, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 16, 2009TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Cerilliant
Julphar
Colorcon
Chubb
Baxter
US Department of Justice
Chinese Patent Office

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