Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072927
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1991 | 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 |
|---|---|---|---|---|---|
| 03/01/2024 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/01/2024 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2021 | SUPPL-42 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2021 | SUPPL-40 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
LORAZEPAM
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 |