Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084122
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/17/1974 | 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 |
|---|---|---|---|---|---|
| 11/24/2008 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 02/13/2003 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/13/1995 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 06/09/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1995 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 10/07/1994 | SUPPL-32 | Labeling |
Label is not available on this site. |
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| 03/30/1994 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/05/1991 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/01/1990 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 10/13/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 09/21/1989 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 10/15/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/15/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1982 | SUPPL-15 | 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 |