Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076463

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NDA 076463 describes HALOPERIDOL DECANOATE, which is a drug marketed by Caplin, Fresenius Kabi Usa, Gland, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in thirteen NDAs. It is available from fifteen suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.

The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.

Summary for 076463

Tradename:	HALOPERIDOL DECANOATE
Applicant:	Sandoz
Ingredient:	haloperidol decanoate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Jun 24, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/ML
Approval Date:	Jun 24, 2005	TE:		RLD:	No

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