Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FUDR | FLOXURIDINE | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/18/1970 | 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 |
---|---|---|---|---|---|
09/20/1999 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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09/15/1997 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/19/1992 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/12/1990 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/30/1990 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/20/1989 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/12/1988 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/01/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
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01/15/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
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01/09/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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09/23/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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04/04/1984 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/14/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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08/22/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
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04/07/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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01/09/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/15/1977 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/23/1977 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/25/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |