Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SLO-BID | THEOPHYLLINE | 200MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
01/31/1985 | 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 |
---|---|---|---|---|---|
12/01/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
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03/19/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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02/23/1991 | SUPPL-33 | Labeling |
Label is not available on this site. |
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07/26/1990 | SUPPL-32 | Labeling |
Label is not available on this site. |
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12/16/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/1991 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1990 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1990 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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03/27/1990 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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01/19/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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12/31/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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12/31/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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07/09/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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07/23/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/24/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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12/31/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |