Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071404
Company: SANDOZ

Products on ANDA 071404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/21/1987	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
01/04/2008	SUPPL-34	Labeling		Label is not available on this site.
06/15/2005	SUPPL-24	Labeling		Label is not available on this site.
03/31/1993	SUPPL-14	Labeling		Label is not available on this site.
10/14/1988	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071404

LORAZEPAM

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATIVAN	LORAZEPAM	1MG	TABLET;ORAL	Prescription	Yes	AB	017794	BAUSCH
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	203572	AUROLIFE PHARMA LLC
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	078203	LEADING
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	077754	OXFORD PHARMS
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	071141	SANDOZ
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	071404	SANDOZ
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	076045	SUN PHARM INDS LTD
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	072927	WATSON LABS