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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078347

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NDA 078347 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, Baxter Hlthcare Corp, Cycle Pharms Ltd, Par Pharm, Teva Pharms Usa, Vintage, Pharm Assoc, Sagent Pharms, Mylan Labs Ltd, Akorn, 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 six NDAs. It is available from thirty-five 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: 078347

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 078347

Suppliers and Packaging for NDA: 078347

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL
haloperidol lactate
 INJECTABLE;INJECTION 078347 ANDA Pfizer Laboratories Div Pfizer Inc 0069-0113 0069-0113-02 25 VIAL in 1 CARTON (0069-0113-02) > 1 mL in 1 VIAL (0069-0113-01)
HALOPERIDOL
haloperidol lactate
 INJECTABLE;INJECTION 078347 ANDA General Injectables and Vaccines, Inc. 52584-426 52584-426-00 1 VIAL in 1 BAG (52584-426-00) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Sep 14, 2009TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
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Fish and Richardson
Cantor Fitzgerald
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Daiichi Sankyo

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