Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065033
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BLEOMYCIN SULFATE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/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 |
|---|---|---|---|---|---|---|---|
| 06/27/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65033ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/21/2013 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2011 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/03/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |