اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BLENOXANE از شرکت BRISTOL MYERS SQUIBB
New Drug Application (NDA): 050443
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLENOXANE | BLEOMYCIN SULFATE | EQ 15 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| BLENOXANE | BLEOMYCIN SULFATE | EQ 30 UNITS BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1973 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
UNKNOWN |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/10/2010 | SUPPL-36 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050443s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050443s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/050443Orig1s036.pdf |
||
| 03/21/2003 | SUPPL-35 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50443slr035_blenoxane_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50443slr035ltr.pdf |
||
| 03/20/2002 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/03/2000 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1999 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/25/1999 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/30/2004 | SUPPL-27 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50443slr027ltr.pdf |
|
| 09/30/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050443s026_blenoxane.pdf |
|
| 02/20/1996 | SUPPL-25 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/21/1994 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/30/1991 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1994 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1994 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/1983 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/26/1983 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1983 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/13/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/15/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/31/1976 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1976 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 10/08/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/05/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1974 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/10/2010 | SUPPL-36 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050443s036lbl.pdf | |
| 03/21/2003 | SUPPL-35 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50443slr035_blenoxane_lbl.pdf |
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