An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Patient 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-Package Insert, Labeling-Patient 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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021481s033lbl.pdf
08/15/2019	SUPPL-33	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021481s033lbl.pdf
12/27/2018	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021481s032lbl.pdf
12/27/2018	SUPPL-32	Labeling-Patient 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

Top