Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 022575
Company: SHIRE HUMAN GENETIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VPRIV VELAGLUCERASE ALFA 400 UNITS/VIAL INJECTABLE;INTRAVENOUS Prescription None No No
VPRIV VELAGLUCERASE ALFA 200 UNITS/VIAL POWDER;INTRAVENOUS Discontinued 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
02/26/2010 ORIG-1 Approval N/A; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2020 SUPPL-26 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022575s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022575Orig1s026ltr.pdf
11/06/2019 SUPPL-23 Supplement

Label is not available on this site.

07/30/2019 SUPPL-22 Supplement

Label is not available on this site.

01/11/2016 SUPPL-18 Supplement

Label is not available on this site.

05/05/2015 SUPPL-17 Supplement

Label is not available on this site.

02/03/2015 SUPPL-16 Supplement

Label is not available on this site.

12/02/2014 SUPPL-15 Supplement

Label is not available on this site.

06/18/2014 SUPPL-14 Supplement

Label is not available on this site.

10/02/2013 SUPPL-13 Supplement

Label is not available on this site.

11/21/2013 SUPPL-12 Supplement

Label is not available on this site.

06/03/2013 SUPPL-11 Supplement

Label is not available on this site.

07/11/2014 SUPPL-10 Supplement

Label is not available on this site.

03/26/2013 SUPPL-9 Supplement

Label is not available on this site.

02/11/2014 SUPPL-8 Supplement

Label is not available on this site.

03/26/2013 SUPPL-7 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/10/2020 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022575s026lbl.pdf

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