Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/11/1976 | 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 |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-97 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/28/2024 | SUPPL-91 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1997 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1995 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 02/08/1994 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1988 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/1988 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1985 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/11/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 213386 | AMNEAL |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 040392 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 212629 | GRANULATION TECH |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 087342 | HIKMA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 083677 | MYLAN |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 089247 | SUN PHARM INDUSTRIES |
| PREDNISONE | PREDNISONE | 20MG | TABLET;ORAL | Prescription | No | AB | 085161 | WATSON LABS |