Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075689
Company: FRESENIUS KABI USA

Products on ANDA 075689

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 075689

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75689ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/22/2025	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
01/13/2025	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
01/13/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-20	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
09/15/2015	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/15/2015	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/06/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/14/2009	SUPPL-10	Labeling		Label is not available on this site.
10/30/2008	SUPPL-9	Labeling		Label is not available on this site.
12/05/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
10/07/2002	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/24/2001	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 075689

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