Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018487
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | AB | 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 |
FUROSEMIDE
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 018569 | EPIC PHARMA LLC |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 216629 | GRAVITI PHARMS |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 018823 | HIKMA |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078010 | IPCA LABS LTD |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 077293 | LEADING |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 018487 | MYLAN |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076796 | PRINSTON INC |
| LASIX | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 016273 | VALIDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 018569 | EPIC PHARMA LLC |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 216629 | GRAVITI PHARMS |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 018823 | HIKMA |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078010 | IPCA LABS LTD |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 077293 | LEADING |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 018487 | MYLAN |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076796 | PRINSTON INC |
| LASIX | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 016273 | VALIDUS PHARMS |