Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062336
Company: BRISTOL MYERS
Company: BRISTOL MYERS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MUTAMYCIN | MITOMYCIN | 5MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MUTAMYCIN | MITOMYCIN | 20MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MUTAMYCIN | MITOMYCIN | 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 08/24/1981 | 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-26 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/17/2000 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 01/06/2000 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/22/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/31/1997 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 09/16/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 11/28/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |