Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1987 | 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 |
|---|---|---|---|---|---|
| 11/05/2020 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2020 | SUPPL-39 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/05/2020 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/11/2012 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/070434s032lbl.pdf | |
| 01/26/2011 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/04/2009 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 03/28/2007 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/23/2002 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/2000 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/22/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/14/1992 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/28/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/12/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/12/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/11/2012 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/070434s032lbl.pdf |