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Last Updated: June 9, 2023

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, SCS, Teva, Teva Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, 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, Cycle, Duramed Pharms Barr, Innogenix, Lederle, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sandoz, Strides Pharma, Upsher Smith Labs, Zydus Pharms Usa, Hospira, Meitheal, Sandoz Inc, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic, and is included in one hundred and five NDAs. It is available from twenty-nine 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. Fourteen 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Harvard Business School

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