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
AGGRASTAT از شرکت MEDICURE
New Drug Application (NDA): 020913
Company: MEDICURE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Discontinued |
None |
No | No |
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | No |
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 05/14/1998 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/11/2020 | SUPPL-28 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020913Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020913Orig1s028ltr.pdf |
|||
| 05/16/2019 | SUPPL-26 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020912Orig1s027,%20020913Orig1s026ltr.pdf |
||
| 09/07/2016 | SUPPL-22 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf |
||
| 06/16/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/2015 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020912Orig1s021,020913Orig1s018ltr.pdf |
||
| 06/06/2012 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020912s018,020913s017ltr.pdf |
||
| 03/05/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/2002 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s010ltr.pdf |
|
| 06/17/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913s009ltr.pdf |
|
| 07/24/2002 | SUPPL-8 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20913slr008and20912slr009ltr.pdf |
|
| 09/25/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-913S007_Aggrastat.pdf |
|
| 03/23/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20913s6ltr.pdf |
|
| 04/20/2000 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/11/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20912-s004_aggrasat.pdf |
|
| 06/09/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/09/1999 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_Aggrastat.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/11/2020 | SUPPL-28 |
Manufacturing (CMC) |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020913Orig1s028lbl.pdf | |
| 05/16/2019 | SUPPL-26 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020912s027,020913s026lbl.pdf | |
| 09/07/2016 | SUPPL-22 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020912s024,020913s022lbl.pdf |
| 04/21/2015 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020912s021,020913s018lbl.pdf | |
| 06/06/2012 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020912s018,020913s017lbl.pdf | |
| 07/09/1999 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20912S001_AGGRASTAT_prntlbl.pdf | |
| 05/14/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20913lbl.pdf |
AGGRASTAT
SOLUTION;INTRAVENOUS; EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020913 | MEDICURE |
| TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206888 | GLAND PHARMA LTD |
نظرات کاربران