BUMEX از شرکت VALIDUS PHARMS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BUMEX از شرکت VALIDUS PHARMS

New Drug Application (NDA): 018226

Company: VALIDUS PHARMS

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
BUMEXBUMETANIDE0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**INJECTABLE;INJECTIONDiscontinued

None

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

Type 3 – New Dosage Form

STANDARD

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
10/29/2002SUPPL-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

10/29/2002SUPPL-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

02/24/1999SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

02/10/1998SUPPL-19 Labeling

Label is not available on this site.

10/21/1993SUPPL-18 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

03/01/1991SUPPL-15 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

01/05/1989SUPPL-11 Labeling

Label is not available on this site.

09/06/1985SUPPL-7 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

08/01/1984SUPPL-2 Efficacy

Label is not available on this site.

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

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
10/29/2002SUPPL-25

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf
10/29/2002SUPPL-24

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-225S018_Bumex_prntlbl.pdf
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