Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
08/27/1981 | 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 |
---|---|---|---|---|---|
03/08/2016 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018487Orig1s043ltr.pdf | |
02/12/2010 | SUPPL-40 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018487s040ltr.pdf |
11/04/2008 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
09/25/2001 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/25/2001 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/07/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/25/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/05/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/06/1997 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
04/29/1996 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
01/07/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/15/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
04/13/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
05/06/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
03/18/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
12/27/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
07/05/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
09/19/1989 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/01/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
01/09/1985 | SUPPL-7 | 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 |
---|---|---|---|---|---|
03/08/2016 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf |