Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | AB | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/17/1972 | 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 |
|---|---|---|---|---|---|
| 04/25/2001 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-74 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1997 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1995 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 02/08/1994 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1987 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/1987 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1987 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1987 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1985 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1985 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1983 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1983 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1983 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1983 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1983 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1972 | SUPPL-1 | 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 | 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 | 040256 | VINTAGE PHARMS |
| PREDNISONE | PREDNISONE | 5MG | TABLET;ORAL | Prescription | No | AB | 080356 | WATSON LABS |