Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064084
Company: TEVA PARENTERAL
Company: TEVA PARENTERAL
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 |
---|---|---|---|---|---|---|---|
06/03/1996 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/064084_bleomycin-sulfate_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/30/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/21/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |