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Generated: August 17, 2017

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Details for New Drug Application (NDA): 071617

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NDA 071617 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, Sandoz Inc, Purepac Pharm, Gland Pharma Ltd, Mylan, Zydus Pharms Usa, Abraxis Pharm, Fresenius Kabi Usa, Hospira, and Actavis Mid Atlantic, and is included in one hundred and five NDAs. It is available from thirty-four 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. Eight suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for NDA: 071617

Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 071617

Suppliers and Packaging for NDA: 071617

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
haloperidol lactate
CONCENTRATE;ORAL 071617 ANDA Teva Pharmaceuticals USA, Inc. 0093-9604 0093-9604-12 1 BOTTLE, DROPPER in 1 CARTON (0093-9604-12) > 120 mL in 1 BOTTLE, DROPPER
haloperidol lactate
CONCENTRATE;ORAL 071617 ANDA Teva Pharmaceuticals USA, Inc. 0093-9604 0093-9604-23 1 BOTTLE, DROPPER in 1 CARTON (0093-9604-23) > 15 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 2MG BASE/ML
Approval Date:Dec 1, 1988TE:AARLD:No

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