Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | 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 |
---|---|---|---|---|---|---|---|
05/19/1975 | 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-41 | Labeling-Package Insert |
Label is not available on this site. |
||
12/01/2008 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
07/14/2005 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
10/30/2001 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/22/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
05/31/1995 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/14/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
02/08/1994 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
07/30/1991 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
12/06/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/06/1991 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/15/1990 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
05/30/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/28/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/15/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/27/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/02/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 1.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 084610 | HIKMA |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 201270 | LARKEN LABS INC |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |