Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074893
Company: FRESENIUS KABI USA

Products on ANDA 074893

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	AO	No	No
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074893

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/01/2025	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
06/20/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
06/20/2025	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
06/20/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/30/2016	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/22/2012	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
03/14/2009	SUPPL-13	Labeling		Label is not available on this site.
10/30/2008	SUPPL-12	Labeling		Label is not available on this site.
12/05/2002	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
11/19/1999	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074893

HALOPERIDOL DECANOATE

INJECTABLE;INJECTION; EQ 50MG BASE/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	219168	CAPLIN
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	074893	FRESENIUS KABI USA
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	205241	GLAND
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	216730	MANKIND PHARMA
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	214507	MEITHEAL
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	075440	MYLAN LABS LTD
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	209101	SOMERSET THERAPS LLC
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	211180	ZYDUS PHARMS

INJECTABLE;INJECTION; EQ 100MG BASE/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	219168	CAPLIN
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	074893	FRESENIUS KABI USA
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	205241	GLAND
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	075305	HIKMA
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	216730	MANKIND PHARMA
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	214507	MEITHEAL
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	075440	MYLAN LABS LTD
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	209101	SOMERSET THERAPS LLC
HALOPERIDOL DECANOATE	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AO	211180	ZYDUS PHARMS