Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079196
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/30/2008 | ORIG-1 | Approval |
Label is not available on this site. |
BUMETANIDE
INJECTABLE;INJECTION; 0.25MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216434 | GLAND PHARMA LTD |
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217153 | LUPIN LTD |
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215364 | MSN |
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 219116 | QILU PHARM HAINAN |
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074441 | SAGENT |
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079196 | WEST-WARD PHARMS INT |