Drugs@FDA: FDA-Approved Drugs
Company: UCB INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXACORT | DEXAMETHASONE SODIUM PHOSPHATE | EQ 0.1MG PHOSPHATE/INH | AEROSOL;NASAL | 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 |
---|---|---|---|---|---|---|---|
12/17/1965 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/10/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-32 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-31 | Labeling |
Label is not available on this site. |
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05/03/1994 | SUPPL-30 | Labeling |
Label is not available on this site. |
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09/11/1991 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-26 | Labeling |
Label is not available on this site. |
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05/18/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
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11/18/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
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08/17/1979 | SUPPL-18 | Labeling |
Label is not available on this site. |
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08/06/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/19/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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09/12/1977 | SUPPL-11 | Labeling |
Label is not available on this site. |