Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/10/1983 | 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 |
|---|---|---|---|---|---|
| 07/14/2017 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018823s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018823rig1s044ltr.pdf | |
| 05/10/2012 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/26/2011 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/04/2009 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 03/28/2007 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/23/2002 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-29 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1994 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/05/1991 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/05/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1990 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/23/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1984 | 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 |
|---|---|---|---|---|---|
| 07/14/2017 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018823s044lbl.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 |