Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089654
Company: MURO
Company: MURO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRELONE | PREDNISOLONE | 5MG/5ML | SYRUP;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 |
|---|---|---|---|---|---|---|---|
| 01/17/1989 | 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 |
|---|---|---|---|---|---|
| 12/09/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/28/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/01/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 06/23/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/02/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 07/02/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/02/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |