Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077293
Company: LEADING
Company: LEADING
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 11/09/2005 | 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 |
|---|---|---|---|---|---|
| 05/12/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/12/2016 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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 | 218831 | AUROBINDO PHARMA LTD |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 018569 | EPIC PHARMA LLC |
| FUROSEMIDE | FUROSEMIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 018415 | ESJAY PHARMA |
| 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 | 076796 | PRINSTON INC |
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 | 218831 | AUROBINDO PHARMA LTD |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 018569 | EPIC PHARMA LLC |
| FUROSEMIDE | FUROSEMIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 018415 | ESJAY PHARMA |
| 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 | 076796 | PRINSTON INC |
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 | 218831 | AUROBINDO PHARMA LTD |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 018569 | EPIC PHARMA LLC |
| FUROSEMIDE | FUROSEMIDE | 80MG | TABLET;ORAL | Prescription | No | AB | 018415 | ESJAY PHARMA |
| 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 | 076796 | PRINSTON INC |