ADEMPAS از شرکت BAYER HLTHCARE

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

ADEMPAS از شرکت BAYER HLTHCARE

New Drug Application (NDA): 204819

Company: BAYER HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADEMPAS RIOCIGUAT 0.5MG TABLET;ORAL Prescription

None

Yes No
ADEMPAS RIOCIGUAT 1MG TABLET;ORAL Prescription

None

Yes No
ADEMPAS RIOCIGUAT 1.5MG TABLET;ORAL Prescription

None

Yes No
ADEMPAS RIOCIGUAT 2MG TABLET;ORAL Prescription

None

Yes No
ADEMPAS RIOCIGUAT 2.5MG TABLET;ORAL 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
10/08/2013 ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD; Orphan

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204819Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/10/2020 SUPPL-14 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s014ltr.pdf

11/30/2020 SUPPL-13 REMS – MODIFIED – D-N-A, REMS – MODIFIED – BIFURCATED

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s013ltr.pdf

01/11/2018 SUPPL-11 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819Orig1s011ltr.pdf

12/06/2018 SUPPL-9 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819s009ltr.pdf

02/23/2017 SUPPL-8 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s008ltr.pdf

10/04/2016 SUPPL-7 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204819Orig1s007ltr.pdf

01/17/2017 SUPPL-6 REMS – MODIFIED – D-N-A

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s006ltr.pdf

12/04/2015 SUPPL-4 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf

02/23/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/06/2014 SUPPL-2 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf

06/11/2014 SUPPL-1 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/11/2018 SUPPL-11

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf
02/23/2017 SUPPL-8

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf
01/17/2017 SUPPL-6

REMS – MODIFIED – D-N-A

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf
05/06/2014 SUPPL-2

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf
10/08/2013 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf
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