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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078010
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 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 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 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
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