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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218371
Company: RUBICON

Products on ANDA 218371

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218371

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218371

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

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