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Last Updated: December 22, 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, 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 073037

Tradename:	HALOPERIDOL
Applicant:	Pharm Assoc
Ingredient:	haloperidol lactate
Patents:	0

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 dba PAI Pharma	0121-0581	0121-0581-04	120 mL in 1 BOTTLE (0121-0581-04)
HALOPERIDOL	haloperidol lactate	CONCENTRATE;ORAL	073037	ANDA	PAI Holdings, LLC dba PAI Pharma	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:	RX	Dosage:	CONCENTRATE;ORAL			Strength	EQ 2MG BASE/ML
Approval Date:	Feb 26, 1993	TE:	AA	RLD:	No

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