Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
07/19/1978 | 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 |
---|---|---|---|---|---|
09/30/2021 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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12/01/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
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07/27/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
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08/28/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
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05/31/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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02/14/1995 | SUPPL-18 | Labeling |
Label is not available on this site. |
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02/08/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
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07/02/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
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03/15/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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05/30/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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06/19/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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06/27/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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11/02/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 4MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 088481 | ALVOGEN |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 215106 | AMNEAL |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 217001 | BIONPHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 080399 | PRASCO |
DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS PHARMS |