Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076150
Company: INTL MEDICATION SYS

Products on ANDA 076150

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/2004	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
08/09/2022	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/05/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/13/2012	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 076150

LORAZEPAM

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATIVAN	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018140	HIKMA
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074243	HOSPIRA
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074282	HOSPIRA
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076150	INTL MEDICATION SYS
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	075025	RISING