Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018415
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSEMIDE FUROSEMIDE 20MG TABLET;ORAL Discontinued None No No
FUROSEMIDE FUROSEMIDE 40MG TABLET;ORAL Discontinued None No No
FUROSEMIDE FUROSEMIDE 80MG TABLET;ORAL Discontinued None 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
07/27/1982 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
10/01/2014 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018415Orig1s026ltr.pdf
06/08/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/14/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-22 Labeling

Label is not available on this site.

06/30/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/26/1992 SUPPL-20 Labeling

Label is not available on this site.

08/09/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/09/1989 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-15 Labeling

Label is not available on this site.

11/04/1988 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/06/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/06/1986 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/17/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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