Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017794
Company: BAUSCH
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 |
|---|---|---|---|---|---|
| 01/13/2023 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017794s049lbl.pdf | |
| 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 |