Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/26/1982 | 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-30 | Labeling-Package Insert |
Label is not available on this site. |
||
09/30/2021 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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12/01/2008 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
07/14/2005 | SUPPL-25 | Labeling |
Label is not available on this site. |
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08/28/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
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05/31/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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02/14/1995 | SUPPL-15 | Labeling |
Label is not available on this site. |
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02/08/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/06/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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12/06/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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12/06/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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01/06/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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01/24/1990 | SUPPL-9 | Labeling |
Label is not available on this site. |
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12/06/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/22/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/29/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 216295 | AMNEAL |
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 217538 | BIONPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 218372 | COREPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 087916 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 217696 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 216283 | ZYDUS LIFESCIENCES |