Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018225
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUMEX | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | AB | Yes | No |
| BUMEX | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| BUMEX | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | AB | 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 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 01/17/2024 | SUPPL-29 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018225Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018225Orig1s029ltr.pdf | |
| 08/08/2018 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018225Orig1s028ltr.pdf | |
| 05/04/2017 | SUPPL-26 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018225Orig1s026ltr.pdf | |
| 09/28/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/2010 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018225s024ltr.pdf | |
| 05/13/2003 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18225slr022ltr.pdf |
| 11/09/2001 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/2002 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) Review |
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-18 | Labeling |
Label (PDF)
Letter (PDF) Review |
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-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/10/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/12/1994 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/01/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/11/1991 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1989 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/10/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/06/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/18/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1984 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1985 | SUPPL-2 | Efficacy |
Label is not available on this site. |
||
| 11/29/1983 | 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 |
|---|---|---|---|---|---|
| 01/17/2024 | SUPPL-29 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018225Orig1s029lbl.pdf |
| 08/08/2018 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf | |
| 05/04/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf | |
| 05/04/2017 | SUPPL-26 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf | |
| 01/21/2010 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf | |
| 10/29/2002 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf | |
| 10/29/2002 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf |
BUMEX
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 209724 | AMNEAL PHARMS CO |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 074225 | HERITAGE PHARMA |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 074700 | SANDOZ |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 213458 | TARO |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 209916 | UPSHER SMITH LABS |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 202900 | ZYDUS PHARMS |
| BUMEX | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | Yes | AB | 018225 | VALIDUS PHARMS |
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 209724 | AMNEAL PHARMS CO |
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074225 | HERITAGE PHARMA |
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074700 | SANDOZ |
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 213458 | TARO |
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 209916 | UPSHER SMITH LABS |
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 202900 | ZYDUS PHARMS |
| BUMEX | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 018225 | VALIDUS PHARMS |
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 209724 | AMNEAL PHARMS CO |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 074225 | HERITAGE PHARMA |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 074700 | SANDOZ |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 213458 | TARO |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 209916 | UPSHER SMITH LABS |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 202900 | ZYDUS PHARMS |
| BUMEX | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | Yes | AB | 018225 | VALIDUS PHARMS |