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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 075305

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NDA 075305 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 fourteen suppliers. Additional details are available on the HALOPERIDOL DECANOATE profile page.

The generic ingredient in HALOPERIDOL DECANOATE 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 075305

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

Pharmacology for NDA: 075305

Suppliers and Packaging for NDA: 075305

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075305	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9295	0143-9295-01	1 VIAL in 1 BOX (0143-9295-01) / 1 mL in 1 VIAL
HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075305	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9296	0143-9296-01	1 VIAL in 1 BOX (0143-9296-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/ML
Approval Date:	Sep 28, 1998	TE:	AO	RLD:	No

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