Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018226
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUMEX BUMETANIDE 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
02/28/1983 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2002 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm
10/29/2002 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18225slr018,019,18226slr24,25ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225s018s19_18-226s24s25_Bumex.cfm
02/24/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/06/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1997 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/10/1998 SUPPL-19 Labeling

Label is not available on this site.

10/21/1993 SUPPL-18 Labeling

Label is not available on this site.

06/11/1993 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1992 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1991 SUPPL-15 Labeling

Label is not available on this site.

10/14/1988 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/10/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/05/1989 SUPPL-11 Labeling

Label is not available on this site.

09/06/1985 SUPPL-7 Labeling

Label is not available on this site.

08/08/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/03/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/03/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/14/1984 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/01/1984 SUPPL-2 Efficacy

Label is not available on this site.

11/22/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2002 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf
10/29/2002 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf

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