Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018569
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription AB No No
FUROSEMIDE FUROSEMIDE 20MG 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
10/19/1981 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2016 SUPPL-63 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018569Orig1s063ltr.pdf
06/05/2015 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

10/04/2012 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

11/28/2007 SUPPL-58 Labeling

Label is not available on this site.

12/16/2002 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

04/19/2002 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/2001 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/2001 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/2000 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/03/2000 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/05/1999 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

09/15/1997 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/08/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/13/1994 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/30/1993 SUPPL-40 Labeling

Label is not available on this site.

07/24/1992 SUPPL-39 Labeling

Label is not available on this site.

10/19/1989 SUPPL-38 Labeling

Label is not available on this site.

05/17/1989 SUPPL-37 Labeling

Label is not available on this site.

08/25/1988 SUPPL-36 Labeling

Label is not available on this site.

12/06/1988 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/06/1988 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/06/1988 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/17/1987 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/26/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/27/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

FUROSEMIDE

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

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; 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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