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
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022433s000lbl.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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022433Orig1s019lbl.pdf |
||
| 07/22/2016 | SUPPL-18 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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