Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018487
Company: MYLAN
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
08/27/1981 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
03/08/2016 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018487Orig1s043ltr.pdf
02/12/2010 SUPPL-40 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018487s040ltr.pdf
11/04/2008 SUPPL-38 Labeling

Label is not available on this site.

09/25/2001 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/25/2001 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/06/1997 SUPPL-27 Labeling

Label is not available on this site.

04/29/1996 SUPPL-26 Labeling

Label is not available on this site.

01/07/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/15/1993 SUPPL-24 Labeling

Label is not available on this site.

04/13/1993 SUPPL-22 Labeling

Label is not available on this site.

05/06/1992 SUPPL-21 Labeling

Label is not available on this site.

03/18/1992 SUPPL-20 Labeling

Label is not available on this site.

12/27/1990 SUPPL-19 Labeling

Label is not available on this site.

07/05/1990 SUPPL-18 Labeling

Label is not available on this site.

09/19/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/01/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/01/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/13/1989 SUPPL-13 Labeling

Label is not available on this site.

01/09/1985 SUPPL-7 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
03/08/2016 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018487s043lbl.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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