Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080780
Company: IMPAX LABS
Company: IMPAX 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 |
|---|---|---|---|---|---|---|---|
| 07/13/1973 | 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 |
|---|---|---|---|---|---|
| 10/18/1996 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 10/28/1991 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/13/1989 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 03/16/2001 | SUPPL-39 | Labeling |
Label is not available on this site. |