Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072755
Company: HIKMA

Products on ANDA 072755

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072755

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/1991	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
04/06/2022	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/27/2017	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/29/2007	SUPPL-14	Labeling		Label is not available on this site.
09/14/2007	SUPPL-11	Labeling		Label is not available on this site.
04/20/2001	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/14/2001	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/28/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/08/1994	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072755

LORAZEPAM INTENSOL

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	090260	PHARM ASSOC
LORAZEPAM INTENSOL	LORAZEPAM	2MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	072755	HIKMA