Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022433
Company: ASTRAZENECA
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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 | 208575 | HISUN PHARM HANGZHOU |