Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074441
Company: SAGENT
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. |
||
| 07/08/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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 | 074332 | HOSPIRA |
| BUMETANIDE | BUMETANIDE | 0.25MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215364 | MSN |
| 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 |