Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021481
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUZEON ENFUVIRTIDE 90MG/VIAL INJECTABLE;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
03/13/2003 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021481lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21481ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021481_fuzeon_review.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/15/2019 SUPPL-33 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021481s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021481Orig1s033ltr.pdf
12/27/2018 SUPPL-32 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021481s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021481Orig1s032ltr.pdf
12/02/2015 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021481s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021481Orig1s030ltr.pdf
06/19/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/31/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021481s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021481Orig1s027ltr.pdf
03/13/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/10/2012 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021481s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021481Orig1s025ltr.pdf
09/22/2014 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/28/2011 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021481s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021481s020ltr.pdf
12/22/2009 SUPPL-17 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021481s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021481s017ltr.pdf
12/16/2008 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021481s015ltr.pdf
12/20/2006 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021481s012ltr.pdf
01/19/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021481s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021481s011ltr.pdf
09/29/2006 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021481s010LTR.pdf
08/12/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021481s007ltr.pdf
06/29/2005 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021481s006ltr.pdf
10/15/2004 SUPPL-2 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21481s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21481s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/15/2019 SUPPL-33 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021481s033lbl.pdf
08/15/2019 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021481s033lbl.pdf
12/27/2018 SUPPL-32 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021481s032lbl.pdf
12/27/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021481s032lbl.pdf
12/02/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021481s030lbl.pdf
10/31/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021481s027lbl.pdf
08/10/2012 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021481s025lbl.pdf
04/28/2011 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021481s020lbl.pdf
12/22/2009 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021481s017lbl.pdf
01/19/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021481s011lbl.pdf
12/20/2006 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s012lbl.pdf
09/29/2006 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021481s010lbl.pdf
08/12/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s007lbl.pdf
06/29/2005 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021481s006lbl.pdf
10/15/2004 SUPPL-2 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21481s002lbl.pdf
03/13/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021481lbl.pdf

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