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
BUMETANIDE از شرکت HERITAGE PHARMA
Abbreviated New Drug Application (ANDA): 074225
Company: HERITAGE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 04/24/1995 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/06/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/03/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 01/21/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/12/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/21/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/14/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUMETANIDE
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 | 212019 | RISING |
| BUMETANIDE | BUMETANIDE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074700 | SANDOZ |
| 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; 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 | 212019 | RISING |
| BUMETANIDE | BUMETANIDE | 1MG | TABLET;ORAL | Prescription | No | AB | 074700 | SANDOZ |
| 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; 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 | 212019 | RISING |
| BUMETANIDE | BUMETANIDE | 2MG | TABLET;ORAL | Prescription | No | AB | 074700 | SANDOZ |
| 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 |
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