Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077754
Company: VINTAGE PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/10/2006 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
09/14/2007 SUPPL-2 Labeling

Label is not available on this site.

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 VALEANT INTL
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 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 071589 MYLAN
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077657 MYLAN
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 076045 SUN PHARM INDS LTD
LORAZEPAM LORAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077754 VINTAGE PHARMS
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 VALEANT INTL
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 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 071590 MYLAN
LORAZEPAM LORAZEPAM 1MG TABLET;ORAL Prescription No AB 077657 MYLAN
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 077754 VINTAGE PHARMS
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 VALEANT INTL
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 078203 LEADING PHARMA LLC
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 071591 MYLAN
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 077657 MYLAN
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 077754 VINTAGE PHARMS
LORAZEPAM LORAZEPAM 2MG TABLET;ORAL Prescription No AB 072928 WATSON LABS

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