Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 062926
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RUBEX | DOXORUBICIN HYDROCHLORIDE | 10MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| RUBEX | DOXORUBICIN HYDROCHLORIDE | 50MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| RUBEX | DOXORUBICIN HYDROCHLORIDE | 100MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/13/1989 | 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 |
|---|---|---|---|---|---|
| 11/02/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/24/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1999 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/11/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/24/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
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