Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074276
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Discontinued None No No
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Discontinued None 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
04/15/1994 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
04/05/2005 SUPPL-6 Labeling

Label is not available on this site.

02/19/1999 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/16/1996 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/13/1996 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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