Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071591
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
10/13/1987 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
02/05/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/18/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/10/1993 SUPPL-4 Labeling

Label is not available on this site.

05/31/1991 SUPPL-3 Labeling

Label is not available on this site.

01/31/1990 SUPPL-2 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 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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