ADDYI از شرکت SPROUT 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

ADDYI از شرکت SPROUT PHARMS

New Drug Application (NDA): 022526

Company: SPROUT PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADDYI FLIBANSERIN 100MG 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
08/18/2015 ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022526Orig1s000Ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022526Orig1s000SumRedt.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-9 REMS – MODIFIED – D-N-A

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s009ltr.pdf

10/09/2019 SUPPL-8 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s008ltr.pdf

04/02/2019 SUPPL-7 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022526Orig1s007ltr.pdf

04/11/2019 SUPPL-6

Letter (PDF)

SLC

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/SLC/2019/022526_SLC OrderLtr.pdf

06/16/2017 SUPPL-4 REMS – MODIFIED – D-N-A

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022526Orig1s004ltr.pdf

04/08/2016 SUPPL-2 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022526Orig1s002ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/09/2019 SUPPL-9

REMS – MODIFIED – D-N-A

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s009lbl.pdf
10/09/2019 SUPPL-8

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022526s008lbl.pdf
08/18/2015 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022526lbl.pdf
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