Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/22/1982 | 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 |
---|---|---|---|---|---|
11/24/2008 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
08/28/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/13/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
06/09/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/09/1997 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/09/1997 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/09/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/22/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
10/07/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
03/30/1994 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
05/14/1992 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
06/05/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
12/26/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
10/13/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
05/20/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 1MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | No | AB | 213385 | AMNEAL |
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | No | AB | 215671 | AUROBINDO PHARMA LTD |
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | No | AB | 040584 | ENDO OPERATIONS |
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 087800 | HIKMA |
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | No | AB | 040611 | JUBILANT CADISTA |
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | No | AB | 215246 | NOVITIUM PHARMA |
PREDNISONE | PREDNISONE | 1MG | TABLET;ORAL | Prescription | No | AB | 210785 | STRIDES PHARMA |