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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071211

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NDA 071211 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 071211

Tradename:1
Applicant:1
Ingredient:1
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 0781-1398-10 1000 TABLET in 1 BOTTLE (0781-1398-10)
HALOPERIDOL haloperidol TABLET;ORAL 071211 ANDA Sandoz Inc 0781-1398 0781-1398-01 100 TABLET in 1 BOTTLE (0781-1398-01)

Summary for product number 001

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


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