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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071130
Company: SCIEGEN PHARMS INC

Products on ANDA 071130

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071130

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/1987	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
02/17/2021	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
05/09/1991	SUPPL-9	Labeling		Label is not available on this site.
12/12/1990	SUPPL-8	Labeling		Label is not available on this site.
06/14/1990	SUPPL-7	Labeling		Label is not available on this site.
10/25/1989	SUPPL-6	Labeling		Label is not available on this site.
02/23/1988	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071130

HALOPERIDOL

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

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