Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORMODYNE | LABETALOL HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| NORMODYNE | LABETALOL HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| NORMODYNE | LABETALOL HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| NORMODYNE | LABETALOL HYDROCHLORIDE | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 08/01/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/27/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1993 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/15/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/07/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/16/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/16/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/23/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/05/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/28/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |