Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE INTENSOL | DEXAMETHASONE | 1MG/ML | CONCENTRATE;ORAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|
| 01/05/2024 | SUPPL-35 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/27/2005 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 01/11/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/2001 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/22/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 02/14/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/29/1994 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 08/02/1991 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 12/31/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/31/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/25/1989 | SUPPL-10 | Bioequivalence |
Label is not available on this site. |
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| 11/05/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/22/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/01/1984 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |