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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 075689

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NDA 075689 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 seven NDAs. It is available from thirty-two 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 075689

Tradename:	HALOPERIDOL
Applicant:	Fresenius Kabi Usa
Ingredient:	haloperidol lactate
Patents:	0

Pharmacology for NDA: 075689

Suppliers and Packaging for NDA: 075689

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	075689	ANDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1524	51662-1524-1	1 mL in 1 VIAL (51662-1524-1)
HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	075689	ANDA	Cardinal Health 107, LLC	55154-9553	55154-9553-5	5 VIAL in 1 BAG (55154-9553-5) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 5MG BASE/ML
Approval Date:	Mar 9, 2001	TE:	AP	RLD:	No

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