Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078347
Company: MYLAN LABS LTD

Products on ANDA 078347

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2009	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
10/09/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/03/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078347

HALOPERIDOL

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075689	FRESENIUS KABI USA
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	210356	FRESENIUS KABI USA
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	076774	GLAND PHARMA LTD
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075858	HIKMA
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	078347	MYLAN LABS LTD
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	091637	SAGENT PHARMS
HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	200742	SAGENT PHARMS