Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072928
Company: WATSON LABS
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
10/31/1991 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
09/10/2008 SUPPL-32 Labeling

Label is not available on this site.

04/12/2001 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

09/02/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/02/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/21/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/31/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/01/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/01/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/22/1993 SUPPL-1 Labeling

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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