Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080701
Company: MUTUAL PHARM
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREDNISONE | PREDNISONE | 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 |
|---|---|---|---|---|---|---|---|
| 11/14/1972 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-88 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1994 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/1995 | SUPPL-85 | Labeling |
Label is not available on this site. |
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| 04/04/1994 | SUPPL-84 | Labeling |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1992 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/12/1995 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/05/1991 | SUPPL-78 | Labeling |
Label is not available on this site. |
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| 04/05/1991 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/02/1989 | SUPPL-76 | Labeling |
Label is not available on this site. |
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| 02/05/1986 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |