Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018225
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUMEX BUMETANIDE 1MG TABLET;ORAL Prescription AB Yes No
BUMEX BUMETANIDE 0.5MG TABLET;ORAL Prescription AB Yes No
BUMEX BUMETANIDE 2MG TABLET;ORAL Prescription AB 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 1 - New Molecular Entity 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
08/08/2018 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018225Orig1s028ltr.pdf
05/04/2017 SUPPL-26 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018225Orig1s026ltr.pdf
09/28/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/21/2010 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018225s024ltr.pdf
05/13/2003 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18225slr022ltr.pdf
11/09/2001 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/2002 SUPPL-19 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-18 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-17 Manufacturing (CMC)

Label is not available on this site.

01/06/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1997 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/10/1998 SUPPL-13 Labeling

Label is not available on this site.

08/12/1994 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/21/1993 SUPPL-11 Labeling

Label is not available on this site.

03/01/1991 SUPPL-10 Labeling

Label is not available on this site.

06/11/1991 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1989 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/05/1989 SUPPL-6 Labeling

Label is not available on this site.

09/06/1985 SUPPL-5 Labeling

Label is not available on this site.

12/18/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1984 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1985 SUPPL-2 Efficacy

Label is not available on this site.

11/29/1983 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
08/08/2018 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf
05/04/2017 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf
05/04/2017 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf
01/21/2010 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf
10/29/2002 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf
10/29/2002 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf

BUMEX

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 209724 AMNEAL PHARMS CO
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 074225 HERITAGE PHARMA
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 074700 SANDOZ
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 209916 UPSHER SMITH LABS
BUMETANIDE BUMETANIDE 1MG TABLET;ORAL Prescription No AB 202900 ZYDUS PHARMS
BUMEX BUMETANIDE 1MG TABLET;ORAL Prescription Yes AB 018225 VALIDUS PHARMS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 209724 AMNEAL PHARMS CO
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 074225 HERITAGE PHARMA
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 074700 SANDOZ
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 209916 UPSHER SMITH LABS
BUMETANIDE BUMETANIDE 0.5MG TABLET;ORAL Prescription No AB 202900 ZYDUS PHARMS
BUMEX BUMETANIDE 0.5MG TABLET;ORAL Prescription Yes AB 018225 VALIDUS PHARMS

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 209724 AMNEAL PHARMS CO
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 074225 HERITAGE PHARMA
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 074700 SANDOZ
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 209916 UPSHER SMITH LABS
BUMETANIDE BUMETANIDE 2MG TABLET;ORAL Prescription No AB 202900 ZYDUS PHARMS
BUMEX BUMETANIDE 2MG TABLET;ORAL Prescription Yes AB 018225 VALIDUS PHARMS

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