Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103909
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
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
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

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