Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| 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 |
|---|---|---|---|---|---|---|---|
| 12/04/1985 | 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 |
|---|---|---|---|---|---|
| 12/02/2022 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/02/2019 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/13/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/09/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/14/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 02/13/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/06/1987 | SUPPL-1 | 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 | 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 | 040256 | VINTAGE PHARMS |
| PREDNISONE | PREDNISONE | 10MG | TABLET;ORAL | Prescription | No | AB | 085162 | WATSON LABS |