Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016273
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LASIX | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LASIX | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LASIX | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 07/01/1966 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/08/2018 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016273s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/016273Orig1s069ltr.pdf | |
| 03/04/2016 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016273Orig1s068ltr.pdf | |
| 03/27/2012 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016273s066ltr.pdf | |
| 10/18/2010 | SUPPL-61 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016273s061ltr.pdf | |
| 10/22/2008 | SUPPL-60 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016273s060ltr.pdf |
| 02/08/2006 | SUPPL-57 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016273s057ltr.pdf |
| 01/14/1999 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1997 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1995 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1995 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 11/13/1992 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/01/1992 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/23/1991 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 03/15/1990 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 03/08/1991 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1987 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1983 | SUPPL-43 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/02/1983 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1983 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/02/1982 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/02/1986 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 02/04/1981 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1981 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 07/02/1979 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 02/05/1980 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1978 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 02/09/1977 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/10/1977 | SUPPL-26 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/21/1976 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 03/20/1975 | SUPPL-7 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/08/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016273s069lbl.pdf | |
| 03/04/2016 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf | |
| 03/27/2012 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf | |
| 10/18/2010 | SUPPL-61 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf |
LASIX
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 |