Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORMODYNE | LABETALOL HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 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 |
|---|---|---|---|---|---|
| 11/06/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/05/2001 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/2000 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/25/2000 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 08/10/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1999 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/14/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/09/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1996 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 11/07/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/28/1993 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/16/1991 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/15/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 11/07/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 10/19/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 07/21/1989 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/22/1988 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/19/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/14/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/12/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/31/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 08/31/1987 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/29/1986 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/04/1986 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |