Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016273
Company: US PHARM HOLDINGS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LASIX FUROSEMIDE 40MG TABLET;ORAL Prescription AB Yes No
LASIX FUROSEMIDE 20MG TABLET;ORAL Prescription AB Yes No
LASIX FUROSEMIDE 80MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/01/1966 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2016 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016273Orig1s068ltr.pdf
03/27/2012 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/016273s066ltr.pdf
10/18/2010 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/016273s061ltr.pdf
10/22/2008 SUPPL-60 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016273s060ltr.pdf
02/08/2006 SUPPL-57 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016273s057ltr.pdf
01/14/1999 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/08/1998 SUPPL-55 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/04/1997 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

05/01/1995 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

01/26/1995 SUPPL-51 Labeling

Label is not available on this site.

11/13/1992 SUPPL-50 Labeling

Label is not available on this site.

04/06/1992 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/01/1992 SUPPL-48 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1991 SUPPL-47 Labeling

Label is not available on this site.

03/15/1990 SUPPL-46 Labeling

Label is not available on this site.

03/08/1991 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1987 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/14/1983 SUPPL-43 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/02/1983 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/15/1983 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/02/1982 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/02/1986 SUPPL-38 Labeling

Label is not available on this site.

02/04/1981 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

03/27/1981 SUPPL-35 Labeling

Label is not available on this site.

07/02/1979 SUPPL-34 Labeling

Label is not available on this site.

02/05/1980 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1978 SUPPL-31 Labeling

Label is not available on this site.

04/24/1978 SUPPL-30 Labeling

Label is not available on this site.

04/24/1978 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1978 SUPPL-28 Labeling

Label is not available on this site.

02/09/1977 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/1977 SUPPL-26 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/21/1976 SUPPL-23 Labeling

Label is not available on this site.

03/20/1975 SUPPL-7 Unspecified

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2016 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016273s068lbl.pdf
03/27/2012 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/016273s066lbl.pdf
10/18/2010 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/016273s061lbl.pdf

LASIX

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 078010 IPCA LABS LTD
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 018413 IVAX SUB TEVA PHARMS
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
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Prescription No AB 018823 WEST-WARD PHARMS INT
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 078010 IPCA LABS LTD
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 018413 IVAX SUB TEVA PHARMS
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
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Prescription No AB 018823 WEST-WARD PHARMS INT
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 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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