Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091383
Company: AMNEAL PHARMS

Products on ANDA 091383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	2MG/ML	CONCENTRATE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2009	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
02/12/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/12/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
10/02/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/02/2020	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091383

LORAZEPAM

CONCENTRATE;ORAL; 2MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LORAZEPAM	LORAZEPAM	2MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	091383	AMNEAL PHARMS
LORAZEPAM	LORAZEPAM	2MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	091407	LUPIN LTD
LORAZEPAM	LORAZEPAM	2MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	090260	PHARM ASSOC
LORAZEPAM INTENSOL	LORAZEPAM	2MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	072755	HIKMA