Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078010
Company: IPCA LABS LTD
Company: IPCA LABS LTD
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 |
---|---|---|---|---|---|---|---|
09/18/2006 | 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 |
---|---|---|---|---|---|
05/28/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
05/28/2020 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
11/30/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
01/27/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
07/09/2009 | 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 | 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 |
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 |