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
BUMEX از شرکت VALIDUS PHARMS
New Drug Application (NDA): 018226
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUMEX | BUMETANIDE | 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 02/28/1983 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/29/2002 | SUPPL-25 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm |
||
| 10/29/2002 | SUPPL-24 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm |
||
| 02/24/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1997 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/10/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 06/11/1993 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/01/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/14/1988 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1987 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/10/1987 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/06/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/08/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1984 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/01/1984 | SUPPL-2 | Efficacy |
Label is not available on this site. |
||
| 11/22/1983 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/29/2002 | SUPPL-25 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf | |
| 10/29/2002 | SUPPL-24 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf |
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