AIRDUO DIGIHALER از شرکت TEVA PHARM

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

AIRDUO DIGIHALER از شرکت TEVA PHARM

New Drug Application (NDA): 208799

Company: TEVA PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AIRDUO DIGIHALER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.055MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription

None

Yes No
AIRDUO DIGIHALER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.113MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription

None

Yes No
AIRDUO DIGIHALER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.232MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription

None

Yes No
AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.055MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription

None

Yes No
AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.113MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription

None

Yes No
AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.232MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription

None

Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/27/2017 ORIG-1 Approval

Type 4 – New Combination

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208799Orig1s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/09/2021 SUPPL-21 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208799s021lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208799Orig1s021ltr.pdf

02/21/2020 SUPPL-11 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208799s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208799Orig1s011ltr.pdf

12/20/2017 SUPPL-2 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s002ltr.pdf

03/02/2018 SUPPL-1 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208798Orig1s002,208799Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/09/2021 SUPPL-21

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208799s021lbl.pdf
02/21/2020 SUPPL-11

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208799s011lbl.pdf
03/02/2018 SUPPL-1

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.pdf
12/20/2017 SUPPL-2

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf
01/27/2017 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf
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