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Details for New Drug Application (NDA): 071211

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NDA 071211 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, West-ward Pharms Int, Silarx, Purepac Pharm, Gland Pharma Ltd, Sun Pharm Inds, Mylan, Zydus Pharms Usa, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Actavis Mid Atlantic, and is included in one hundred and four NDAs. It is available from thirty 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: 071211

Tradename:
HALOPERIDOL
Applicant:
Sandoz
Ingredient:
haloperidol
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 071211

Suppliers and Packaging for NDA: 071211

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL
haloperidol
TABLET;ORAL 071211 ANDA Sandoz Inc 0781-1398 0781-1398-01 100 TABLET in 1 BOTTLE (0781-1398-01)
HALOPERIDOL
haloperidol
TABLET;ORAL 071211 ANDA Sandoz Inc 0781-1398 0781-1398-10 1000 TABLET in 1 BOTTLE (0781-1398-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Mar 11, 1988TE:ABRLD:No


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