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
ACTIVASE از شرکت GENENTECH
Biologic License Application (BLA): 103172
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTIVASE | ALTEPLASE | 100MG/VIAL | VIAL; SINGLE-USE | Prescription |
None |
No | No |
| ACTIVASE | ALTEPLASE | 50MG/VIAL | VIAL; SINGLE-USE | Prescription |
None |
No | No |
| CATHFLO ACTIVASE | ALTEPLASE | 2MG/VIAL | VIAL | Prescription |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 11/13/1987 | ORIG-1 | Approval |
N/A |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2020 | SUPPL-5267 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103172Orig1s5267ltr.pdf |
|
| 02/28/2018 | SUPPL-5260 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5260lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103172Orig1s5260ltr.pdf |
||
| 02/28/2018 | SUPPL-5259 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103172Orig1s5259ltr.pdf |
||
| 06/30/2017 | SUPPL-5253 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103172s5253lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103172Orig1s5253ltr.pdf |
||
| 02/13/2015 | SUPPL-5203 | Supplement |
Label for ACTIVASE |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103172s5203lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103172Orig1s5203ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2015/103172Orig1s5203.pdf |
|
| 01/04/2005 | SUPPL-5071 | Supplement |
Label for CATHFLO ACTIVASE |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103172s5071lbl.pdf |
|
| 05/15/2002 | SUPPL-5009 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/altegen051502LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/altegen051502L.htm |
||
| 09/04/2001 | SUPPL-5003 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/altegen090401LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/altegen090401L.htm |
||
| 06/18/1996 | SUPPL-1055 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/altegen061896L.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/alteplase_toc.cfm |
|
| 04/03/1995 | SUPPL-1036 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2018 | SUPPL-5260 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5260lbl.pdf | |
| 02/28/2018 | SUPPL-5259 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5259lbl.pdf | |
| 06/30/2017 | SUPPL-5253 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103172s5253lbl.pdf | |
| 02/13/2015 | SUPPL-5203 |
Labeling |
Label (PDF) |
Label for ACTIVASE |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103172s5203lbl.pdf |
| 01/04/2005 | SUPPL-5071 |
Efficacy |
Label (PDF) |
Label for CATHFLO ACTIVASE |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103172s5071lbl.pdf |
| 05/15/2002 | SUPPL-5009 |
Supplement |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/altegen051502LB.pdf | |
| 09/04/2001 | SUPPL-5003 |
Efficacy |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/altegen090401LB.pdf |
نظرات کاربران