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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076045
Company: SUN PHARM INDS LTD

Products on ANDA 076045

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	AB	No	No
LORAZEPAM	LORAZEPAM	1MG	TABLET;ORAL	Prescription	AB	No	No
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076045

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2001	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76045.ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/29/2009	SUPPL-7	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076045

LORAZEPAM

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATIVAN	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	Yes	AB	017794	BAUSCH
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	203572	AUROLIFE PHARMA LLC
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	078203	LEADING
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	077754	OXFORD PHARMS
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	071141	SANDOZ
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	076045	SUN PHARM INDS LTD
LORAZEPAM	LORAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	072926	WATSON LABS

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

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATIVAN	LORAZEPAM	2MG	TABLET;ORAL	Prescription	Yes	AB	017794	BAUSCH
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	203572	AUROLIFE PHARMA LLC
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	078203	LEADING
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	077754	OXFORD PHARMS
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	071141	SANDOZ
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	076045	SUN PHARM INDS LTD
LORAZEPAM	LORAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	072928	WATSON LABS

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