Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077580
Company: ZYDUS PHARMS USA

• Healthcare Professional Sheet

Products on ANDA 077580

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	AB	No	No
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	AB	No	No
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	AB	No	No
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	AB	No	No
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	AB	No	No
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2007	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
02/23/2017	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
01/07/2015	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/27/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/06/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/25/2008	SUPPL-2	Labeling		Label is not available on this site.
05/29/2008	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077580

HALOPERIDOL

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	218789	AUROBINDO PHARMA LTD
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	071209	CHARTWELL RX
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	071173	INNOGENIX
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	216918	MANKIND PHARMA
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	216004	MSN
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	070278	MYLAN
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	071206	SANDOZ
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	211061	UPSHER SMITH LABS
HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET;ORAL	Prescription	No	AB	077580	ZYDUS PHARMS USA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	218789	AUROBINDO PHARMA LTD
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	071209	CHARTWELL RX
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	071173	INNOGENIX
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	216918	MANKIND PHARMA
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	216004	MSN
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	070278	MYLAN
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	071207	SANDOZ
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	211061	UPSHER SMITH LABS
HALOPERIDOL	HALOPERIDOL	1MG	TABLET;ORAL	Prescription	No	AB	077580	ZYDUS PHARMS USA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	218789	AUROBINDO PHARMA LTD
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	071209	CHARTWELL RX
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	071173	INNOGENIX
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	216918	MANKIND PHARMA
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	216004	MSN
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	070278	MYLAN
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	071131	SCIEGEN PHARMS INC
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	211061	UPSHER SMITH LABS
HALOPERIDOL	HALOPERIDOL	5MG	TABLET;ORAL	Prescription	No	AB	077580	ZYDUS PHARMS USA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	218789	AUROBINDO PHARMA LTD
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	071210	CHARTWELL RX
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	071173	INNOGENIX
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	216918	MANKIND PHARMA
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	216004	MSN
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	070278	MYLAN
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	071132	SCIEGEN PHARMS INC
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	211061	UPSHER SMITH LABS
HALOPERIDOL	HALOPERIDOL	10MG	TABLET;ORAL	Prescription	No	AB	077580	ZYDUS PHARMS USA

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	218789	AUROBINDO PHARMA LTD
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	071211	CHARTWELL RX
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	071173	INNOGENIX
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	216918	MANKIND PHARMA
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	216004	MSN
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	070278	MYLAN
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	211061	UPSHER SMITH LABS
HALOPERIDOL	HALOPERIDOL	20MG	TABLET;ORAL	Prescription	No	AB	077580	ZYDUS PHARMS USA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	218789	AUROBINDO PHARMA LTD
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	071173	INNOGENIX
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	216918	MANKIND PHARMA
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	216004	MSN
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	070278	MYLAN
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	071130	SCIEGEN PHARMS INC
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	211061	UPSHER SMITH LABS
HALOPERIDOL	HALOPERIDOL	2MG	TABLET;ORAL	Prescription	No	AB	077580	ZYDUS PHARMS USA