An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 103172
Company: GENENTECH

Products on BLA 103172

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103172

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.

Labels for BLA 103172

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
09/01/2022	SUPPL-5268	Labeling-Package Insert	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

Top