Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070086
Company: HIKMA
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
01/24/1986 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
05/10/2012 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

01/26/2011 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

05/04/2009 SUPPL-35 Labeling

Label is not available on this site.

03/28/2007 SUPPL-34 Labeling

Label is not available on this site.

05/23/2002 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

05/07/2002 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/07/2002 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/2002 SUPPL-27 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

08/30/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/10/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/22/1997 SUPPL-23 Labeling

Label is not available on this site.

08/28/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/13/1995 SUPPL-21 Labeling

Label is not available on this site.

06/24/1994 SUPPL-20 Labeling

Label is not available on this site.

08/28/1992 SUPPL-19 Labeling

Label is not available on this site.

11/18/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/03/1991 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/18/1990 SUPPL-15 Labeling

Label is not available on this site.

03/13/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/28/1989 SUPPL-13 Labeling

Label is not available on this site.

05/03/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/13/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/19/1989 SUPPL-9 Labeling

Label is not available on this site.

05/06/1988 SUPPL-7 Labeling

Label is not available on this site.

07/12/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/13/1991 SUPPL-3 Labeling

Label is not available on this site.

03/13/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/13/1985 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 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English