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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073037
Company: PHARM ASSOC

Products on ANDA 073037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 2MG BASE/ML	CONCENTRATE;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1993	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
01/22/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
02/23/2017	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/18/2010	SUPPL-13	Labeling-Container/Carton Labels		Label is not available on this site.
02/26/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/12/2009	SUPPL-11	Labeling		Label is not available on this site.
11/25/2008	SUPPL-10	Labeling		Label is not available on this site.
03/27/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/31/1995	SUPPL-3	Labeling		Label is not available on this site.
01/31/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073037

HALOPERIDOL

CONCENTRATE;ORAL; EQ 2MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 2MG BASE/ML	CONCENTRATE;ORAL	Prescription	No	AA	073364	LANNETT CO INC
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 2MG BASE/ML	CONCENTRATE;ORAL	Prescription	No	AA	073037	PHARM ASSOC
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 2MG BASE/ML	CONCENTRATE;ORAL	Prescription	No	AA	218371	RUBICON RESEARCH

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