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Drugs@FDA: FDA-Approved Drugs

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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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022433s006lbl.pdf
01/24/2013 SUPPL-6 Labeling-Package Insert 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
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