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Generated: November 18, 2018

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Details for New Drug Application (NDA): 076774

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NDA 076774 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, SCS, Teva, Teva Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, 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, Sandoz Inc, Somerset Theraps Llc, and Actavis Mid Atlantic, and is included in one hundred and seven NDAs. It is available from thirty-six 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 076774
Tradename:HALOPERIDOL
Applicant:Gland Pharma Ltd
Ingredient:haloperidol lactate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076774
Suppliers and Packaging for NDA: 076774
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 076774 ANDA Breckenridge Pharmaceutical, Inc. 51991-933 51991-933-17 10 SYRINGE in 1 BOX (51991-933-17) > 1 mL in 1 SYRINGE (51991-933-99)
HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 076774 ANDA Gland Pharma Limited 68083-117 68083-117-01 10 SYRINGE in 1 BOX (68083-117-01) > 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 5MG BASE/ML
Approval Date:Aug 25, 2004TE:APRLD:No

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