You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 27, 2026

Details for New Drug Application (NDA): 073037

✉ Email this page to a colleague

« Back to Dashboard

NDA 073037 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, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Creekwood Pharms, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, 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 nine 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. Sixteen 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.