Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213458
Company: TARO
Company: TARO
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 |
---|---|---|---|---|---|---|---|
07/24/2023 | ORIG-1 | Approval | STANDARD |
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 | 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; 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; 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 |