Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075858
Company: HIKMA

Products on ANDA 075858

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075858

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75858ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2025	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
06/23/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
11/21/2016	SUPPL-19	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/10/2011	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/02/2011	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
12/09/2009	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/19/2008	SUPPL-10	Labeling		Label is not available on this site.
05/29/2008	SUPPL-9	Labeling		Label is not available on this site.
02/01/2008	SUPPL-8	Labeling		Label is not available on this site.
10/18/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/04/2002	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 075858

HALOPERIDOL

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075689	FRESENIUS KABI USA
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075858	HIKMA
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	078347	MYLAN LABS LTD
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	091637	SAGENT PHARMS
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	200742	SAGENT PHARMS