Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 0.5MG/5ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/01/1983 | 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 |
---|---|---|---|---|---|
06/05/2024 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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09/30/2021 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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07/27/2005 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/01/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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09/14/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
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02/14/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
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02/08/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
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08/02/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/26/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/16/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/16/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1984 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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05/01/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/31/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |