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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/30/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/017794s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/017794Orig1s049ltr.pdf | |
| 02/05/2021 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017794s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/017794Orig1s048ltr.pdf | |
| 12/16/2016 | SUPPL-44 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017794Orig1s044ltr.pdf | |
| 04/18/2007 | SUPPL-35 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017794s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017794s035_LTR.pdf | |
| 04/20/1988 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/04/1987 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1987 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1987 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1987 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/30/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1986 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/26/1984 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/24/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 09/29/1983 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/03/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1980 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/02/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/02/1980 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/24/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/20/1978 | SUPPL-3 | Labeling |
Label is not available on this site. |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017794s044lbl.pdf | |
| 12/16/2016 | SUPPL-44 | Labeling-Medication Guide | 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 |
ATIVAN
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATIVAN | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 017794 | BAUSCH |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROLIFE PHARMA LLC |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 078203 | LEADING |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077754 | OXFORD PHARMS |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 071141 | SANDOZ |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 076045 | SUN PHARM INDS LTD |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 072926 | WATSON LABS |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ATIVAN | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | Yes | AB | 017794 | BAUSCH |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROLIFE PHARMA LLC |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 078203 | LEADING |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 077754 | OXFORD PHARMS |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 071141 | SANDOZ |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 071404 | SANDOZ |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 076045 | SUN PHARM INDS LTD |
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 072927 | WATSON LABS |
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 | BAUSCH |
| LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROLIFE PHARMA LLC |
| LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 078203 | LEADING |
| LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077754 | OXFORD PHARMS |
| 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 | 072928 | WATSON LABS |