Drugs@FDA: FDA-Approved Drugs
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. |
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05/11/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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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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