Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103172
Company: GENENTECH
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 |
---|---|---|---|---|---|
09/01/2022 | SUPPL-5268 | Supplement |
Label (PDF)
Letter (PDF) |
Label for ACTIVASE | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103172s5268lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/103172Orig1s5268ltr.pdf |
10/08/2020 | SUPPL-5267 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103172Orig1s5267ltr.pdf |
02/28/2018 | SUPPL-5260 | Supplement |
Label (PDF)
Letter (PDF) |
Label for CATHFLO ACTIVASE | 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 |
Label (PDF)
Letter (PDF) |
Label for ACTIVASE | 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 |
Label (PDF)
Letter (PDF) |
Label for ACTIVASE | 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 (PDF)
Letter (PDF) Review (PDF) |
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 (PDF)
|
Label for CATHFLO ACTIVASE | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103172s5071lbl.pdf |
05/15/2002 | SUPPL-5009 | Supplement |
Label (PDF)
Letter |
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 |
Label (PDF)
Letter |
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 |
Letter (PDF)
Review |
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 |
---|---|---|---|---|---|
09/01/2022 | SUPPL-5268 | Labeling-Package Insert | Label (PDF) | Label for ACTIVASE | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103172s5268lbl.pdf |
09/01/2022 | SUPPL-5268 | Labeling-Container/Carton Labels | Label (PDF) | Label for ACTIVASE | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/103172s5268lbl.pdf |
02/28/2018 | SUPPL-5260 | Labeling-Package Insert | Label (PDF) | Label for CATHFLO ACTIVASE | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5260lbl.pdf |
02/28/2018 | SUPPL-5259 | Labeling-Package Insert | Label (PDF) | Label for ACTIVASE | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103172s5259lbl.pdf |
06/30/2017 | SUPPL-5253 | Labeling-Package Insert | Label (PDF) | Label for ACTIVASE | 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 |