Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017794
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATIVAN LORAZEPAM 0.5MG TABLET;ORAL Prescription AB Yes No
ATIVAN LORAZEPAM 1MG TABLET;ORAL Prescription AB Yes No
ATIVAN LORAZEPAM 2MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/05/2021 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017794s048lbl.pdf
12/16/2016 SUPPL-44 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf
12/16/2016 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf
04/18/2007 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf

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