Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071206
Company: SANDOZ

Products on ANDA 071206

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071206

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/1986	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-35	Labeling-Package Insert		Label is not available on this site.
12/06/2010	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
07/16/2009	SUPPL-28	Labeling		Label is not available on this site.
09/08/2008	SUPPL-27	Labeling		Label is not available on this site.
05/29/2008	SUPPL-24	Labeling		Label is not available on this site.
04/02/2008	SUPPL-23	Labeling		Label is not available on this site.
09/05/2002	SUPPL-21	Labeling		Label is not available on this site.
10/16/2001	SUPPL-18	Labeling		Label is not available on this site.
09/21/1998	SUPPL-13	Labeling		Label is not available on this site.
04/20/1990	SUPPL-10	Labeling		Label is not available on this site.
06/01/1989	SUPPL-8	Labeling		Label is not available on this site.
09/09/1988	SUPPL-7	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071206

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