AKYNZEO از شرکت HELSINN 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

AKYNZEO از شرکت HELSINN HLTHCARE

New Drug Application (NDA): 205718

Company: HELSINN HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKYNZEO NETUPITANT; PALONOSETRON HYDROCHLORIDE 300MG;EQ 0.5MG BASE CAPSULE;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
10/10/2014 ORIG-1 Approval

Type 1 – New Molecular Entity and Type 4 – New Combination

STANDARD

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205718Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205718Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/02/2021 SUPPL-9 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205718Orig1s009ltr.pdf

12/28/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/12/2016 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/20/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

04/27/2015 SUPPL-3 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf

04/29/2015 SUPPL-2 Labeling-Package Insert

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf

02/16/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/02/2021 SUPPL-9

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf
04/29/2015 SUPPL-2

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf
04/27/2015 SUPPL-3

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf
10/10/2014 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf
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