Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050484
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 12/19/1979 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/01/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/22/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/11/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/06/1987 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
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| 12/03/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/26/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |