BROVANA از شرکت SUNOVION

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
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BROVANA از شرکت SUNOVION

New Drug Application (NDA): 021912

Company: SUNOVION

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
BROVANAARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION;INHALATIONPrescription

AN

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
10/06/2006ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021912s000tr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912_brovana_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/29/2019SUPPL-32 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021912Orig1s032ltr.pdf

12/12/2016SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/11/2016SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/06/2015SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/16/2015SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/11/2015SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/25/2014SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/27/2014SUPPL-23 Labeling-Package Insert, Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf

02/26/2013SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/14/2013SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/09/2012SUPPL-20 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf

08/09/2012SUPPL-18

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf

09/02/2011SUPPL-16 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf

02/16/2011SUPPL-15 Labeling, REMS-Modified

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf

02/01/2011SUPPL-12 REMS-Proposal

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf

06/02/2010SUPPL-11 Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf

06/22/2010SUPPL-8 Labeling-Medication Guide

Label is not available on this site.

07/14/2011SUPPL-6 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf

12/20/2007SUPPL-1 Manufacturing (CMC)-Packaging

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
05/29/2019SUPPL-32

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf
02/27/2014SUPPL-23

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf
02/27/2014SUPPL-23

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf
07/14/2011SUPPL-6

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf
02/16/2011SUPPL-15

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf
02/16/2011SUPPL-15

REMS-Modified

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf
06/02/2010SUPPL-11

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf
12/20/2007SUPPL-1

Manufacturing (CMC)-Packaging

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf
10/06/2006ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf

BROVANA

SOLUTION;INHALATION; EQ 0.015MG BASE/2ML

TE Code = AN

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION;INHALATIONPrescriptionNoAN213762AXAR PHARMS INC
ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION;INHALATIONPrescriptionNoAN207306CIPLA
ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION;INHALATIONPrescriptionNoAN213132GLENMARK PHARMS LTD
BROVANAARFORMOTEROL TARTRATEEQ 0.015MG BASE/2MLSOLUTION;INHALATIONPrescriptionYesAN021912SUNOVION
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