Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 50MG | 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 |
---|---|---|---|---|---|---|---|
09/09/1977 | 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-47 | Labeling-Package Insert |
Label is not available on this site. |
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11/24/2008 | SUPPL-41 | Labeling |
Label is not available on this site. |
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03/14/2003 | SUPPL-33 | Labeling |
Label is not available on this site. |
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08/28/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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07/13/1995 | SUPPL-26 | Labeling |
Label is not available on this site. |
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06/09/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1995 | SUPPL-24 | Labeling |
Label is not available on this site. |
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10/07/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
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03/30/1994 | SUPPL-22 | Labeling |
Label is not available on this site. |
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06/05/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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01/16/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
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10/13/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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09/19/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
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02/23/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
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01/07/1988 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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01/07/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/24/1984 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/1983 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/22/1983 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
PREDNISONE
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 215672 | AUROBINDO PHARMA LTD |
PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 084283 | HIKMA |
PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 040362 | JUBILANT CADISTA |
PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 211575 | NOVITIUM PHARMA |
PREDNISONE | PREDNISONE | 50MG | TABLET;ORAL | Prescription | No | AB | 208412 | STRIDES PHARMA |