Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073364
Company: LANNETT CO INC

Products on ANDA 073364

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 073364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/1993	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-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/23/2017	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
04/30/2009	SUPPL-8	Labeling		Label is not available on this site.
01/10/2002	SUPPL-4	Labeling		Label is not available on this site.
09/22/2000	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/08/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/27/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 073364

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