Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085085
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISOLONE | PREDNISOLONE | 5MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/29/1976 | 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 |
|---|---|---|---|---|---|
| 04/06/1994 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 03/03/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/01/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1987 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/15/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/15/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/15/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/23/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/19/1984 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 10/04/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |