Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071141
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription AB No No
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription AB No No
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription AB No No
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
12/10/2018 SUPPL-50 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/16/2008 SUPPL-32 Labeling

Label is not available on this site.

06/15/2005 SUPPL-22 Labeling

Label is not available on this site.

11/02/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/18/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-12 Labeling

Label is not available on this site.

12/27/1989 SUPPL-11 Bioequivalence

Label is not available on this site.

06/18/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/14/1988 SUPPL-5 Labeling

Label is not available on this site.

04/12/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/14/1988 SUPPL-3 Labeling

Label is not available on this site.

08/17/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/12/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LORAZEPAM

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 078826 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 077396 ANI PHARMS INC
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 203572 AUROLIFE PHARMA LLC
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 077657 MYLAN
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 072928 WATSON LABS

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 078826 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077396 ANI PHARMS INC
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 203572 AUROLIFE PHARMA LLC
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077657 MYLAN
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 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 078826 AMNEAL PHARMS
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 077396 ANI PHARMS INC
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 203572 AUROLIFE PHARMA LLC
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 077657 MYLAN
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 072927 WATSON LABS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English