Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1974 | 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 |
|---|---|---|---|---|---|
| 02/21/2019 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2002 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/03/2000 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1998 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1997 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/09/1994 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 04/14/1994 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 07/06/1994 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1982 | SUPPL-13 | 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 |