Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084612
Company: HIKMA
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 |
| DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | AB | Yes | No |
| DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 03/15/1991 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 06/05/2024 | SUPPL-33 | Labeling-Package Insert, Labeling |
Label is not available on this site. |
||
| 09/30/2021 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/27/2005 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/31/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1995 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/08/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/02/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/15/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/30/1991 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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 | No | AB | 218372 | COREPHARMA |
| 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 LIFESCIENCES |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
| DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 218372 | COREPHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |
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 | No | AB | 218372 | COREPHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | 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 |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
| DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET;ORAL | Prescription | No | AB | 218372 | COREPHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET;ORAL | Prescription | No | AB | 216284 | ZYDUS LIFESCIENCES |
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 | No | AB | 218372 | COREPHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 201270 | PHARMOBEDIENT |
| DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |
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 | 084612 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 217696 | NOVITIUM PHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET;ORAL | Prescription | No | AB | 216283 | ZYDUS LIFESCIENCES |
TABLET;ORAL; 6MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 088481 | ALVOGEN |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 215106 | AMNEAL |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 217695 | APOTEX |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 217001 | BIONPHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 218372 | COREPHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | Yes | AB | 084612 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | Yes | AB | 088316 | HIKMA |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 215604 | NOVITIUM PHARMA |
| DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET;ORAL | Prescription | No | AB | 216282 | ZYDUS LIFESCIENCES |