BREO ELLIPTA از شرکت GLAXO GRP LTD

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

New Drug Application (NDA): 204275

Company: GLAXO GRP LTD

Products on NDA 204275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.1MG/INH;EQ 0.025MG BASE/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
BREO ELLIPTA	FLUTICASONE FUROATE; VILANTEROL TRIFENATATE	0.2MG/INH;EQ 0.025MG BASE/INH	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/10/2013	ORIG-1	Approval	Type 1 – New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204275Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204275Orig1s000TOC.cfm

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

05/10/2013

ORIG-1

Approval

Type 1 – New Molecular Entity

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204275Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204275Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2019	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204275s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204275Orig1s017ltr.pdf
12/20/2017	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204275Orig1s015ltr.pdf
05/15/2017	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204275Orig1s012ltr.pdf
10/31/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s011ltr.pdf
02/16/2016	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s009ltr.pdf
10/21/2015	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
08/11/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/15/2015	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s004ltr.pdf
03/02/2015	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s002ltr.pdf
04/30/2015	SUPPL-1	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s001ltr.pdf

Labels for NDA 204275

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
01/07/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204275s017lbl.pdf
12/20/2017	SUPPL-15	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s015lbl.pdf
05/15/2017	SUPPL-12	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s012lbl.pdf
10/31/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s011lbl.pdf
02/16/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s009lbl.pdf
09/15/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s004lbl.pdf
04/30/2015	SUPPL-1	Efficacy-New Dosing Regimen	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s001lbl.pdf
03/02/2015	SUPPL-2	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf
05/10/2013	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf

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منبع : www.accessdata.fda.gov

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