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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103909
Company: GENENTECH

Products on BLA 103909

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TNKASE	TENECTEPLASE	50MG/VIAL	VIAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103909

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
02/28/2025	SUPPL-5197	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103909s5197lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/103909Orig1s5197ltr.pdf
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.

Labels for BLA 103909

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/28/2025	SUPPL-5197	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/103909s5197lbl.pdf
01/05/2024	SUPPL-5195	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103909Orig15195Correctedlbl.pdf
01/05/2024	SUPPL-5195	Labeling-Container/Carton Labels	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

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