Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074711
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 150MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
| MEXILETINE HYDROCHLORIDE | MEXILETINE HYDROCHLORIDE | 250MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 02/26/1997 | 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 |
|---|---|---|---|---|---|
| 04/27/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/04/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |