Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/1972 | 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 |
|---|---|---|---|---|---|
| 11/24/2008 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 03/11/1997 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1995 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1997 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1995 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 10/07/1994 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 03/30/1994 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 06/07/1991 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 05/15/1991 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/26/1989 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/13/1989 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 09/22/1988 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1988 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1988 | SUPPL-31 | Bioequivalence |
Label is not available on this site. |
||
| 02/21/1984 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 213385 | AMNEAL |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 040256 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 212629 | GRANULATION TECH |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 080352 | HIKMA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 080292 | MYLAN |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 209727 | STRIDES PHARMA |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 089247 | SUN PHARM INDUSTRIES |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 080356 | WATSON LABS |