Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103172
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
06/30/2017 SUPPL-5253 Supplement Label (PDF)
Letter (PDF)
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
06/30/2017 SUPPL-5253 Labeling-Package Insert Label (PDF) 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

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