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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090260
Company: PHARM ASSOC

Products on ANDA 090260

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 090260

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2010	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
11/23/2010	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 090260

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

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