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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 None 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
11/04/2024 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022433Orig1s037ltr.pdf
03/22/2024 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022433Orig1s035ltr.pdf
05/09/2022 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022433s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022433Orig1s034ltr.pdf
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
11/04/2024 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s037lbl.pdf
03/22/2024 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s035lbl.pdf
05/09/2022 SUPPL-34 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022433s034lbl.pdf
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 208567 ALKEM LABS LTD
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208541 DR REDDYS
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208575 HISUN PHARM HANGZHOU
TICAGRELOR TICAGRELOR 90MG TABLET;ORAL Prescription No AB 208599 PRINSTON INC
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