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Last Updated: June 13, 2024

Details for New Drug Application (NDA): 073037

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NDA 073037 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, SCS, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, Actavis Group, Aiping Pharm Inc, Aurobindo Pharma Ltd, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sciegen Pharms Inc, Strides Pharma, Upsher Smith Labs, Zydus Pharms Usa, Hospira, Meitheal, Sandoz, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic, and is included in one hundred and nine NDAs. It is available from thirty-three 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. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
Summary for 073037
Applicant:Pharm Assoc
Ingredient:haloperidol lactate
Formulation / Manufacturing:see details
Pharmacology for NDA: 073037
Suppliers and Packaging for NDA: 073037
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HALOPERIDOL haloperidol lactate CONCENTRATE;ORAL 073037 ANDA PAI Holdings, LLC 0121-0581 0121-0581-04 120 mL in 1 BOTTLE (0121-0581-04)
HALOPERIDOL haloperidol lactate CONCENTRATE;ORAL 073037 ANDA PAI Holdings, LLC 0121-0581 0121-0581-05 10 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrengthEQ 2MG BASE/ML
Approval Date:Feb 26, 1993TE:AARLD:No

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