Drugs@FDA: FDA-Approved Drugs
Company: PRECISION DOSE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
THEOPHYLLINE | THEOPHYLLINE | 80MG/15ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
03/16/1979 | 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 |
---|---|---|---|---|---|
10/23/2000 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/06/1997 | SUPPL-59 | Labeling |
Label is not available on this site. |
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01/14/1997 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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04/04/1996 | SUPPL-57 | Labeling |
Label is not available on this site. |
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07/07/1992 | SUPPL-56 | Labeling |
Label is not available on this site. |
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04/23/1991 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
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09/28/1990 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1991 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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03/28/1990 | SUPPL-52 | Labeling |
Label is not available on this site. |
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10/04/1989 | SUPPL-51 | Labeling |
Label is not available on this site. |
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02/08/1989 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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02/08/1989 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1988 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1988 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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12/15/1988 | SUPPL-45 | Labeling |
Label is not available on this site. |
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03/17/1987 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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02/18/1983 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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11/21/1970 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |