Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018823
Company: HIKMA
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
11/10/1983 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
07/14/2017 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018823s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018823rig1s044ltr.pdf
05/10/2012 SUPPL-42 Labeling-Package Insert

Label is not available on this site.

01/26/2011 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

05/04/2009 SUPPL-39 Labeling

Label is not available on this site.

03/28/2007 SUPPL-38 Labeling

Label is not available on this site.

09/20/2002 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/23/2002 SUPPL-32 Manufacturing (CMC)-Facility

Label is not available on this site.

04/29/2002 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/29/2002 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/2002 SUPPL-29 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/30/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/2001 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/10/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/22/1997 SUPPL-25 Labeling

Label is not available on this site.

08/28/1996 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/23/1994 SUPPL-23 Labeling

Label is not available on this site.

08/28/1992 SUPPL-22 Labeling

Label is not available on this site.

08/05/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/05/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/04/1990 SUPPL-19 Labeling

Label is not available on this site.

03/28/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/28/1989 SUPPL-17 Labeling

Label is not available on this site.

02/23/1990 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/14/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/14/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/01/1989 SUPPL-13 Labeling

Label is not available on this site.

03/29/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/03/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/03/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/03/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/14/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/09/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/14/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/01/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/14/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018823s044lbl.pdf

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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