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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021481
Company: ROCHE

Products on NDA 021481

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUZEON	ENFUVIRTIDE	90MG/VIAL	INJECTABLE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021481

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

Labels for NDA 021481

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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