Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018413
Company: AVET
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/1983 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
08/07/2015 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

07/11/2012 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

12/27/2010 SUPPL-58 Labeling-Package Insert

Label is not available on this site.

03/12/2009 SUPPL-54 Labeling

Label is not available on this site.

02/06/2009 SUPPL-51 Labeling

Label is not available on this site.

02/06/2009 SUPPL-49 Labeling

Label is not available on this site.

07/29/2002 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

10/24/2002 SUPPL-38 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.

04/14/2001 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

02/09/2000 SUPPL-34 Labeling

Label is not available on this site.

01/28/2000 SUPPL-33 Manufacturing (CMC)-Facility

Label is not available on this site.

02/09/2000 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/08/1999 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/08/1999 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/08/1999 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/08/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/01/1999 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/30/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/03/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/11/1992 SUPPL-20 Labeling

Label is not available on this site.

10/27/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/20/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

08/20/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/07/1992 SUPPL-16 Labeling

Label is not available on this site.

06/25/1991 SUPPL-15 Labeling

Label is not available on this site.

08/05/1988 SUPPL-13 Labeling

Label is not available on this site.

04/25/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/25/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/25/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/15/1986 SUPPL-2 Manufacturing (CMC)

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 018413 AVET
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 018413 AVET
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

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