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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074282
Company: HOSPIRA

Products on ANDA 074282

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
LORAZEPAM	LORAZEPAM	4MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074282

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/1994	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
04/29/2022	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
04/22/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
04/22/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
04/30/2007	SUPPL-7	Labeling		Label is not available on this site.
12/09/1998	SUPPL-4	Labeling		Label is not available on this site.
12/09/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074282

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

INJECTABLE;INJECTION; 4MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATIVAN	LORAZEPAM	4MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018140	HIKMA
LORAZEPAM	LORAZEPAM	4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074243	HOSPIRA
LORAZEPAM	LORAZEPAM	4MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074282	HOSPIRA

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