Drugs@FDA: FDA-Approved Drugs
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TONOCARD | TOCAINIDE HYDROCHLORIDE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| TONOCARD | TOCAINIDE HYDROCHLORIDE | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/09/1984 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2001 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/18/2001 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/27/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/08/1992 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/10/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/07/1989 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1988 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/21/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1986 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1985 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1986 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/30/1985 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |