Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103909
Company: GENENTECH
Company: GENENTECH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TNKASE | TENECTEPLASE | 50MG/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 |
---|---|---|---|---|---|---|---|
06/02/2000 | ORIG-1 | Approval | N/A |
Label
Letter Review |
https://web.archive.org/web/20160803130402/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093370.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/tenegen060200L.htm https://web.archive.org/web/20090119110643/https://www.fda.gov/cder/biologics/products/tenegen060200.htm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/05/2024 | SUPPL-5195 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103909Orig15195Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103909Orig15195Correctedltr.pdf | |
03/31/2023 | SUPPL-5194 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103909s5194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103909Orig1s5194ltr.pdf | |
02/28/2018 | SUPPL-5187 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103909s5187lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103909Orig1s5187ltr.pdf | |
05/13/2008 | SUPPL-5109 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/05/2024 | SUPPL-5195 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103909Orig15195Correctedlbl.pdf | |
01/05/2024 | SUPPL-5195 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103909Orig15195Correctedlbl.pdf | |
03/31/2023 | SUPPL-5194 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103909s5194lbl.pdf | |
02/28/2018 | SUPPL-5187 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103909s5187lbl.pdf | |
06/02/2000 | ORIG-1 | Approval | https://web.archive.org/web/20160803130402/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093370.htm |