Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085162
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 11/12/1976 | 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 |
|---|---|---|---|---|---|
| 04/25/2001 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1997 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1995 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 02/08/1994 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1984 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1983 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 213386 | AMNEAL |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 040256 | ENDO OPERATIONS |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 212629 | GRANULATION TECH |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 084122 | HIKMA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 088832 | MYLAN |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 089247 | SUN PHARM INDUSTRIES |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 085162 | WATSON LABS |