Drugs@FDA: FDA-Approved Drugs
New Drug Application:
Company:
Company:
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|
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 |
|---|---|---|---|---|---|
| 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. |
||
| 03/31/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
LORAZEPAM
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 | 077396 | ANI PHARMS |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 203572 | AUROBINDO PHARMA |
| LORAZEPAM | LORAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 218597 | GRAVITI PHARMS |
| 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 |