Is there a generic for Haloperidol decanoate?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Haloperidol decanoate, referencing the brand HALDOL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Haloperidol decanoate?

HALDOL (NDA 018701, JANSSEN PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Haloperidol decanoate are approved?

Haloperidol decanoate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Haloperidol decanoate

Haloperidol decanoate: 1 brand, 13 generics; first approved Jan 14, 1986; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 13 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

Ask AI

HALDOLRLD
JANSSEN PHARMSNDA 01870119862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 100MG BASE/ML INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Generic (ANDA) products (13)

Abbreviated applications

Ask AI

HALOPERIDOL DECANOATE
CAPLINANDA 21916820252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATERS
MANKIND PHARMAANDA 21673020232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
MEITHEALANDA 21450720212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
ZYDUS PHARMSANDA 21118020192 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
SOMERSET THERAPS LLCANDA 20910120182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
GLANDANDA 20524120172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
SANDOZANDA 07646320052 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 100MG BASE/ML INJECTABLE INJECTION Discontinued -
HALOPERIDOL DECANOATE
MYLAN LABS LTDANDA 07544020002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
HOSPIRAANDA 07517620002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 100MG BASE/ML INJECTABLE INJECTION Discontinued -
HALOPERIDOL DECANOATE
TEVA PHARMS USAANDA 07539319992 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 100MG BASE/ML INJECTABLE INJECTION Discontinued -
HALOPERIDOL DECANOATE
HIKMAANDA 0753051998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO
HALOPERIDOL DECANOATE
HIKMAANDA 0748111998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Discontinued -
HALOPERIDOL DECANOATE
FRESENIUS KABI USAANDA 07489319972 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 50MG BASE/ML INJECTABLE INJECTION Rx AO
EQ 100MG BASE/ML INJECTABLE INJECTION Rx AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 50MG BASE/ML	INJECTABLE	INJECTION	Rx	AO
EQ 100MG BASE/ML	INJECTABLE	INJECTION	Rx	AO

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

Ask AI

First approval

Jan 14, 1986

41 yr 4 mo ago

Most recent approval

May 13, 2025

1 yr 6 mo ago

Approvals span 1986–2025 across 14 FDA applications.

Brand (NDA) 17%

Generic (ANDA) 1393%

Haloperidol decanoate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Assyro Intelligence

Ask anything about Haloperidol decanoate

Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.

Evaluating for a team? Book a demo