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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217598
Company: FRESENIUS KABI USA

Products on ANDA 217598

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 217598

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217598

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

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