Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076796
Company: PRINSTON INC

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
03/26/2004 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
05/31/2020 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
05/31/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
05/09/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
01/27/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
02/20/2009 SUPPL-5 Labeling

Label is not available on this site.
08/09/2007 SUPPL-4 Labeling

Label is not available on this site.
05/01/2006 SUPPL-2 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 018823 HIKMA
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 078010 IPCA LABS LTD
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 077293 LEADING PHARMA LLC
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 018487 MYLAN
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 076796 PRINSTON INC
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 018569 SANDOZ
LASIX FUROSEMIDE 20MG TABLET;ORAL Prescription Yes AB 016273 US PHARM HOLDINGS

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 018823 HIKMA
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 078010 IPCA LABS LTD
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 077293 LEADING PHARMA LLC
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 018487 MYLAN
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 076796 PRINSTON INC
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 018569 SANDOZ
LASIX FUROSEMIDE 40MG TABLET;ORAL Prescription Yes AB 016273 US PHARM HOLDINGS

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 070086 HIKMA
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Prescription No AB 078010 IPCA LABS LTD
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Prescription No AB 077293 LEADING PHARMA LLC
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Prescription No AB 070082 MYLAN
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Prescription No AB 076796 PRINSTON INC
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Prescription No AB 018569 SANDOZ
LASIX FUROSEMIDE 80MG TABLET;ORAL Prescription Yes AB 016273 US PHARM HOLDINGS

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