Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084613
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/03/1975 | 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-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2008 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/14/2005 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 05/31/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/14/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 02/08/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 07/02/1991 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 03/15/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 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. |
||
| 05/06/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/15/1985 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/27/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
DEXAMETHASONE
TABLET;ORAL; 0.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | Yes | AB | 084613 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |