Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040014
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 07/10/1995 | 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 |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/01/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/02/2015 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2015 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/25/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |