Drugs@FDA: FDA-Approved Drugs
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | AB | No | No |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | AB | No | No |
| FUROSEMIDE | FUROSEMIDE | 80MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/19/1981 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2020 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018569s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/018569Orig1s066ltr.pdf | |
| 10/07/2016 | SUPPL-63 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018569Orig1s063ltr.pdf |
| 06/05/2015 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/2012 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2007 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/2001 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/2000 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2000 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1997 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1996 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1993 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 07/24/1992 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 10/19/1989 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/17/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1987 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1985 | SUPPL-21 | 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 |
|---|---|---|---|---|---|
| 12/22/2020 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018569s066lbl.pdf |
FUROSEMIDE
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 |
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; 80MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 018569 | EPIC PHARMA LLC |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 216629 | GRAVITI PHARMS |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070086 | HIKMA |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 078010 | IPCA LABS LTD |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 077293 | LEADING |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 070082 | MYLAN |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 076796 | PRINSTON INC |
| LASIX | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | Yes | AB | 016273 | VALIDUS PHARMS |