Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 05/22/1972 | 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 |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/2024 | SUPPL-53 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/31/2024 | SUPPL-52 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/31/2024 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1998 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1997 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1997 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 06/15/1994 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/09/1994 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/15/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/07/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/14/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1982 | SUPPL-13 | 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 |