Drugs@FDA: FDA-Approved Drugs
Company: SCHERING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEO-DUR | THEOPHYLLINE | 200MG | 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 |
---|---|---|---|---|---|---|---|
01/31/1980 | 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-38 | Labeling |
Label is not available on this site. |
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08/18/1997 | SUPPL-35 | Labeling |
Label is not available on this site. |
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08/18/1997 | SUPPL-34 | Labeling |
Label is not available on this site. |
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07/17/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
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06/22/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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06/22/1988 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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10/26/1989 | SUPPL-29 | Labeling |
Label is not available on this site. |
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12/18/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/14/1986 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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03/14/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/14/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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02/18/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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09/20/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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01/03/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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07/18/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1983 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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01/12/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |