ADCETRIS از شرکت SEATTLE GENETICS

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

ADCETRIS از شرکت SEATTLE GENETICS

Biologic License Application (BLA): 125388

Company: SEATTLE GENETICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADCETRIS BRENTUXIMAB VEDOTIN 50MG/VIAL INJECTABLE; INJECTION Prescription

None

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/19/2011 ORIG-1 Approval

N/A; Orphan

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125388s000,125399s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388_adcetris_toc.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/15/2019 SUPPL-100 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125388s100lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125388Orig1s100ltr.pdf

11/16/2018 SUPPL-99 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s099ltr.pdf

03/20/2018 SUPPL-97 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s097ltr.pdf

11/09/2017 SUPPL-94 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125388Orig1s094ltr.pdf

09/28/2016 SUPPL-88 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s088ltr.pdf

03/04/2016 SUPPL-84 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s084ltr.pdf

08/17/2015 SUPPL-81 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf

08/17/2015 SUPPL-80 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf

11/23/2014 SUPPL-78 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf

11/23/2014 SUPPL-56 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf

08/19/2013 SUPPL-45 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125388Orig1s045ltr.pdf

01/13/2012 SUPPL-11 Supplement

Label is not available on this site.

08/19/2011 SUPPL-6 Supplement

Label is not available on this site.

01/13/2012 SUPPL-5 Supplement

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125388s005ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/15/2019 SUPPL-100

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125388s100lbl.pdf
11/16/2018 SUPPL-99

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf
03/20/2018 SUPPL-97

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf
11/09/2017 SUPPL-94

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf
09/28/2016 SUPPL-88

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf
03/04/2016 SUPPL-84

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf
08/17/2015 SUPPL-81

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
08/17/2015 SUPPL-80

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
11/23/2014 SUPPL-78

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
11/23/2014 SUPPL-56

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
08/19/2013 SUPPL-45

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf
01/13/2012 SUPPL-5

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf
08/19/2011 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf
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