Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070082
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
10/29/1986 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
08/01/2016 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

08/01/2016 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

11/04/2008 SUPPL-22 Labeling

Label is not available on this site.

10/22/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

12/07/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/05/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/06/1997 SUPPL-13 Labeling

Label is not available on this site.

04/24/1996 SUPPL-12 Labeling

Label is not available on this site.

01/07/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/15/1993 SUPPL-10 Labeling

Label is not available on this site.

04/13/1993 SUPPL-8 Labeling

Label is not available on this site.

05/06/1992 SUPPL-7 Labeling

Label is not available on this site.

03/18/1992 SUPPL-6 Labeling

Label is not available on this site.

12/27/1990 SUPPL-5 Labeling

Label is not available on this site.

05/03/1990 SUPPL-4 Labeling

Label is not available on this site.

01/31/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/16/1990 SUPPL-2 Labeling

Label is not available on this site.

06/10/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

FUROSEMIDE

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 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
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Prescription No AB 070086 WEST-WARD PHARMS INT
LASIX FUROSEMIDE 80MG TABLET;ORAL Prescription Yes AB 016273 US PHARM HOLDINGS

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