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BRILINTA از شرکت ASTRAZENECA

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BRILINTA از شرکت ASTRAZENECA

New Drug Application (NDA): 022433

Company: ASTRAZENECA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRILINTA TICAGRELOR 90MG TABLET;ORAL Prescription

AB

Yes Yes
BRILINTA TICAGRELOR 60MG TABLET;ORAL Prescription

AB

Yes 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
07/20/2011 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/2011/022433s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022433Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2021 SUPPL-32 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022433s032lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022433Orig1s032ltr.pdf

02/17/2021 SUPPL-31 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022433s031lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022433Orig1s031ltr.pdf

09/15/2020 SUPPL-30 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022433Orig1s030ltr.pdf

11/05/2020 SUPPL-29 Efficacy-New Indication

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s029lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022433Orig1s029ltr.pdf

05/28/2020 SUPPL-28 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s028lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022433Orig1s028ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/022433Orig1s028.pdf

10/24/2019 SUPPL-25 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022433s025lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022433Orig1s025ltr.pdf

04/03/2019 SUPPL-23 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022433s023lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022433Orig1s023ltr.pdf

03/09/2018 SUPPL-22 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022433s022lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022433Orig1s022ltr.pdf

09/23/2016 SUPPL-20 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s020lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022433Orig1s020ltr.pdf

08/11/2016 SUPPL-19 Labeling-Container/Carton Labels

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433Orig1s019lbl.pdf

07/22/2016 SUPPL-18 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022433Orig1s018ltr.pdf

09/21/2015 SUPPL-17 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s017ltr.pdf

09/16/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/03/2015 SUPPL-15 Efficacy-New Indication

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s015ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022433Orig1s015TOC.cfm

06/24/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/26/2015 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022433Orig1s013ltr.pdf

07/18/2014 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/07/2014 SUPPL-11 Labeling-Container/Carton Labels

Label is not available on this site.

12/13/2013 SUPPL-10 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s010lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s010ltr.pdf

10/30/2013 SUPPL-9 REMS-Modified

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s009ltr.pdf

03/29/2013 SUPPL-8 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s008ltr.pdf

01/24/2013 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s006lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022433Orig1s006ltr.pdf

11/09/2012 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/05/2012 SUPPL-4 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
08/10/2021 SUPPL-32

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022433s032lbl.pdf
02/17/2021 SUPPL-31

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022433s031lbl.pdf
11/05/2020 SUPPL-29

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s029lbl.pdf
09/15/2020 SUPPL-30

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s030lbl.pdf
05/28/2020 SUPPL-28

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022433s028lbl.pdf
10/24/2019 SUPPL-25

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022433s025lbl.pdf
04/03/2019 SUPPL-23

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022433s023lbl.pdf
03/09/2018 SUPPL-22

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022433s022lbl.pdf
09/23/2016 SUPPL-20

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s020lbl.pdf
08/11/2016 SUPPL-19

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433Orig1s019lbl.pdf
07/22/2016 SUPPL-18

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433s018lbl.pdf
09/21/2015 SUPPL-17

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s017lbl.pdf
09/03/2015 SUPPL-15

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s015lbl.pdf
03/26/2015 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022433s013lbl.pdf
12/13/2013 SUPPL-10

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s010lbl.pdf
03/29/2013 SUPPL-8

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s008lbl.pdf
01/24/2013 SUPPL-6

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s006lbl.pdf
01/24/2013 SUPPL-6

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s006lbl.pdf
07/20/2011 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022433s000lbl.pdf

BRILINTA

TABLET;ORAL; 90MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BRILINTA TICAGRELOR 90MG TABLET;ORAL Prescription Yes AB 022433 ASTRAZENECA
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208575 HISUN PHARM HANGZHOU
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208597 MYLAN
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208596 SIGMAPHARM LABS LLC

TABLET;ORAL; 60MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BRILINTA TICAGRELOR 60MG TABLET;ORAL Prescription Yes AB 022433 ASTRAZENECA
TICAGRELOR TICAGRELOR 60MG TABLET;ORAL Prescription No AB 208597 MYLAN
حتما بخوانید : CEFOTAN از شرکت TELIGENT
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