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DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071206

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NDA 071206 describes HALOPERIDOL, which is a drug marketed by Solopak, Smith And Nephew, Sandoz, Morton Grove, Frontida Biopharm, Watson Labs, Teva, Marsam Pharms Llc, Duramed Pharms Barr, Teva Pharms, Alpharma, SCS, Royce Labs, Lederle, Claris, Cycle Pharms Ltd, Par Pharm, Teva Pharms Usa, Vintage, Pharm Assoc, Sagent Pharms, Mylan Labs Ltd, Quantum Pharmics, Eurohlth Intl Sarl, Silarx, Purepac Pharm, Gland Pharma Ltd, Sun Pharm Inds, Mylan, Zydus Pharms Usa, Abraxis Pharm, Fresenius Kabi Usa, West-ward Pharms Int, Hospira, and Actavis Mid Atlantic, and is included in one hundred and four 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. Seven suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for NDA: 071206


Pharmacology for NDA: 071206

Suppliers and Packaging for NDA: 071206

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 071206 ANDA Sandoz Inc 0781-1391 0781-1391-01 100 TABLET in 1 BOTTLE (0781-1391-01)
TABLET;ORAL 071206 ANDA Sandoz Inc 0781-1391 0781-1391-10 1000 TABLET in 1 BOTTLE (0781-1391-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Nov 17, 1986TE:ABRLD:No

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