Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| THEO-DUR | THEOPHYLLINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| THEO-DUR | THEOPHYLLINE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/12/1979 | 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 |
|---|---|---|---|---|---|
| 01/10/2002 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 01/05/2001 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/08/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1997 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 08/18/1997 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 07/17/1996 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 06/22/1988 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1988 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/26/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 12/18/1986 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1986 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1986 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1986 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/14/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/14/1986 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/14/1986 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1986 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1985 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/20/1985 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/03/1984 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |