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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074243
Company: HOSPIRA

Products on ANDA 074243

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 074243

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/1994	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
09/25/2023	SUPPL-45	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/29/2022	SUPPL-41	Labeling-Package Insert		Label is not available on this site.
06/09/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
06/09/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/13/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
04/27/2007	SUPPL-6	Labeling		Label is not available on this site.
03/05/2002	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/14/2001	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/21/1999	SUPPL-3	Labeling		Label is not available on this site.
04/21/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/22/1995	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 074243

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	217598	FRESENIUS KABI USA
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	074243	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

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