Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PREDNISOLONE | PREDNISOLONE | 5MG | 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 |
---|---|---|---|---|---|---|---|
01/17/1972 | 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 |
---|---|---|---|---|---|
09/16/2007 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/2001 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/25/2001 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/30/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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03/30/1994 | SUPPL-43 | Labeling |
Label is not available on this site. |
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03/26/1991 | SUPPL-42 | Labeling |
Label is not available on this site. |
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01/28/1991 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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06/03/1985 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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06/03/1985 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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12/27/1983 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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11/22/1983 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
PREDNISOLONE
TABLET;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PREDNISOLONE | PREDNISOLONE | 5MG | TABLET;ORAL | Prescription | No | AB | 215673 | AUROBINDO PHARMA LTD |
PREDNISOLONE | PREDNISOLONE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 080354 | WATSON LABS |
PREDNISOLONE | PREDNISOLONE | 5MG | TABLET;ORAL | Prescription | No | AB | 218083 | ZHEJIANG XIANJU |