Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200742
Company: SAGENT PHARMS

Products on ANDA 200742

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200742

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/02/2011	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/08/2018	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/12/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200742

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