Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022311
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MOZOBIL PLERIXAFOR 24MG/1.2ML (20MG/ML) SOLUTION;SUBCUTANEOUS Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/15/2008 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022311s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/19/2020 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022311s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022311Orig1s022ltr.pdf
05/30/2019 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022311s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022311Orig1s020ltr.pdf
12/01/2017 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022311s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022311s018ltr.pdf
05/12/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

08/04/2015 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022311s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022311Orig1s016ltr.pdf
12/04/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022311Orig1s015ltr.pdf
11/12/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/04/2013 SUPPL-13 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022311Orig1s013ltr.pdf
02/26/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/14/2010 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022311s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/19/2020 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022311s022lbl.pdf
05/30/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022311s020lbl.pdf
12/01/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022311s018lbl.pdf
08/04/2015 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022311s016lbl.pdf
12/04/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf
06/04/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf
06/04/2013 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf
06/14/2010 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf
12/15/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf

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