Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071404
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
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.

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 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

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