Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074535
Company: WATSON LABS INC
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
09/12/1996 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
12/08/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

11/01/1999 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

04/28/2000 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/17/1999 SUPPL-2 Labeling

Label is not available on this site.

06/10/1997 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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