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
AGGRENOX از شرکت BOEHRINGER INGELHEIM
New Drug Application (NDA): 020884
Company: BOEHRINGER INGELHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AGGRENOX | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/22/1999 | ORIG-1 | Approval |
Type 4 – New Combination |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/13/2021 | SUPPL-40 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020884s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020884Orig1s040ltr.pdf |
||
| 12/11/2019 | SUPPL-39 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020884s039lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020884Orig1s039ltr.pdf |
||
| 11/09/2018 | SUPPL-37 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020884s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020884Orig1s037ltr.pdf |
||
| 11/09/2015 | SUPPL-35 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020884Orig1s035ltr.pdf |
||
| 05/30/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/2012 | SUPPL-30 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020884Orig1s030ltr.pdf |
||
| 10/01/2009 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020884s018ltr.pdf |
||
| 11/28/2006 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020884s014ltr.pdf |
||
| 03/26/2007 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020884s012ltr.pdf |
||
| 01/28/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20884slr007ltr.pdf |
|
| 06/20/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/2001 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20884S3ltr.pdf |
|
| 10/17/2000 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/2001 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/13/2021 | SUPPL-40 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020884s040lbl.pdf | |
| 12/11/2019 | SUPPL-39 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020884s039lbledt.pdf | |
| 11/09/2018 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020884s037lbl.pdf | |
| 11/09/2015 | SUPPL-35 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020884s035lbl.pdf | |
| 09/07/2012 | SUPPL-30 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020884s030lbl.pdf | |
| 10/01/2009 | SUPPL-18 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020884s018lbl.pdf | |
| 03/26/2007 | SUPPL-12 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020884s012lbl.pdf | |
| 11/28/2006 | SUPPL-14 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020884s014lbl.pdf | |
| 08/10/2001 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20884s1lbl.pdf | |
| 11/22/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_prntlbl.pdf |
AGGRENOX
CAPSULE, EXTENDED RELEASE;ORAL; 25MG;200MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AGGRENOX | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020884 | BOEHRINGER INGELHEIM |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206392 | AMNEAL PHARMS |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078804 | BARR |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 209048 | DR REDDYS |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210318 | GLENMARK PHARMS SA |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 207944 | PAR PHARM INC |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206739 | SANDOZ INC |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208572 | SUN PHARM |
| ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206753 | ZYDUS PHARMS |
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