Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 013413
Company: UCB INC
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, METERED;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 09/17/1962 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/03/1994 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 09/11/1991 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/18/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 08/15/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/06/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |