Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070473
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LORAZEPAM | LORAZEPAM | 1MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1985 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1991 | SUPPL-14 | Bioequivalence |
Label is not available on this site. |
||
| 03/25/1991 | SUPPL-13 | Bioequivalence |
Label is not available on this site. |
||
| 04/01/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |