Drugs@FDA: FDA-Approved Drugs
Company: SAGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
01/27/1995 | 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 |
---|---|---|---|---|---|
03/08/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
11/20/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
08/28/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/08/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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07/08/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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07/08/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/05/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/05/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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05/24/1995 | SUPPL-1 | Labeling |
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 |