Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080850
Company: AM REGENT
Company: AM REGENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1972 | 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 |
|---|---|---|---|---|---|
| 04/09/2010 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2010 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |