Last Updated: November 8, 2026

Details for New Drug Application (NDA): 200742

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NDA 200742 describes HALOPERIDOL, which is a drug marketed by Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon Research, 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, Ajanta Pharma Ltd, Alembic, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Creekwood Pharms, Duramed Pharms Barr, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sciegen Pharms, Strides Pharma Intl, Zydus Pharms Usa, Caplin, Gland, Hospira, Meitheal, Sandoz, Somerset Theraps Llc, Zydus Pharms, and Actavis Mid Atlantic, and is included in one hundred and eleven 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 three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for 200742

Tradename:	HALOPERIDOL
Applicant:	Sagent Pharms
Ingredient:	haloperidol lactate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Sep 2, 2011	TE:	AP	RLD:	No

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