BUMEX از شرکت VALIDUS PHARMS

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BUMEX از شرکت VALIDUS PHARMS

New Drug Application (NDA): 018225

Company: VALIDUS PHARMS

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
BUMEXBUMETANIDE1MGTABLET;ORALPrescription

AB

YesNo
BUMEXBUMETANIDE0.5MGTABLET;ORALPrescription

AB

YesNo
BUMEXBUMETANIDE2MGTABLET;ORALPrescription

AB

YesNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
02/28/1983ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
08/08/2018SUPPL-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

05/04/2017SUPPL-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

09/28/2015SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/21/2010SUPPL-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

05/13/2003SUPPL-22 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18225slr022ltr.pdf

11/09/2001SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/2002SUPPL-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

10/29/2002SUPPL-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

02/24/1999SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

02/10/1998SUPPL-13 Labeling

Label is not available on this site.

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

Label is not available on this site.

10/21/1993SUPPL-11 Labeling

Label is not available on this site.

03/01/1991SUPPL-10 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

01/05/1989SUPPL-6 Labeling

Label is not available on this site.

09/06/1985SUPPL-5 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

06/14/1985SUPPL-2 Efficacy

Label is not available on this site.

11/29/1983SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
08/08/2018SUPPL-28

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018225s028lbl.pdf
05/04/2017SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf
05/04/2017SUPPL-26

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018225s026lbl.pdf
01/21/2010SUPPL-24

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018225s024lbl.pdf
10/29/2002SUPPL-19

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf
10/29/2002SUPPL-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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
BUMETANIDEBUMETANIDE1MGTABLET;ORALPrescriptionNoAB209724AMNEAL PHARMS CO
BUMETANIDEBUMETANIDE1MGTABLET;ORALPrescriptionNoAB074225HERITAGE PHARMA
BUMETANIDEBUMETANIDE1MGTABLET;ORALPrescriptionNoAB212019RISING
BUMETANIDEBUMETANIDE1MGTABLET;ORALPrescriptionNoAB074700SANDOZ
BUMETANIDEBUMETANIDE1MGTABLET;ORALPrescriptionNoAB209916UPSHER SMITH LABS
BUMETANIDEBUMETANIDE1MGTABLET;ORALPrescriptionNoAB202900ZYDUS PHARMS
BUMEXBUMETANIDE1MGTABLET;ORALPrescriptionYesAB018225VALIDUS PHARMS

TABLET;ORAL; 0.5MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
BUMETANIDEBUMETANIDE0.5MGTABLET;ORALPrescriptionNoAB209724AMNEAL PHARMS CO
BUMETANIDEBUMETANIDE0.5MGTABLET;ORALPrescriptionNoAB074225HERITAGE PHARMA
BUMETANIDEBUMETANIDE0.5MGTABLET;ORALPrescriptionNoAB212019RISING
BUMETANIDEBUMETANIDE0.5MGTABLET;ORALPrescriptionNoAB074700SANDOZ
BUMETANIDEBUMETANIDE0.5MGTABLET;ORALPrescriptionNoAB209916UPSHER SMITH LABS
BUMETANIDEBUMETANIDE0.5MGTABLET;ORALPrescriptionNoAB202900ZYDUS PHARMS
BUMEXBUMETANIDE0.5MGTABLET;ORALPrescriptionYesAB018225VALIDUS PHARMS

TABLET;ORAL; 2MG

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
BUMETANIDEBUMETANIDE2MGTABLET;ORALPrescriptionNoAB209724AMNEAL PHARMS CO
BUMETANIDEBUMETANIDE2MGTABLET;ORALPrescriptionNoAB074225HERITAGE PHARMA
BUMETANIDEBUMETANIDE2MGTABLET;ORALPrescriptionNoAB212019RISING
BUMETANIDEBUMETANIDE2MGTABLET;ORALPrescriptionNoAB074700SANDOZ
BUMETANIDEBUMETANIDE2MGTABLET;ORALPrescriptionNoAB209916UPSHER SMITH LABS
BUMETANIDEBUMETANIDE2MGTABLET;ORALPrescriptionNoAB202900ZYDUS PHARMS
BUMEXBUMETANIDE2MGTABLET;ORALPrescriptionYesAB018225VALIDUS PHARMS
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