Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071141
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORAZEPAM | LORAZEPAM | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 04/21/1987 | 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 |
|---|---|---|---|---|---|
| 07/21/2023 | SUPPL-53 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2021 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2018 | SUPPL-50 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/16/2008 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 06/15/2005 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/27/1989 | SUPPL-11 | Bioequivalence |
Label is not available on this site. |
||
| 06/18/1991 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/12/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/17/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LORAZEPAM
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 |
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 |