ROCHE FDA Approval NDA 021481

Application #021481

Documents

Letter	2003-03-20
Letter	2005-07-08
Letter	2005-08-16
Letter	2007-01-25
Letter	2008-12-24
Letter	2009-12-31
Letter	2011-05-03
Letter	2013-11-06
Letter	2015-12-03
Label	2005-07-07
Label	2012-08-22
Label	2015-12-08
Letter	2004-10-18
Letter	2006-10-02
Letter	2006-12-28
Letter	2012-08-15
Label	2003-03-18
Label	2004-10-18
Label	2005-08-15
Label	2006-10-02
Label	2007-01-24
Label	2006-12-28
Label	2010-01-04
Label	2011-04-29
Label	2013-11-01
Review	2003-07-23
Letter	2018-12-30
Label	2019-01-02
Letter	2019-08-16
Label	2019-08-16

Application Sponsors

NDA 021481

ROCHE

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;SUBCUTANEOUS

90MG/VIAL

FUZEON

ENFUVIRTIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2003-03-13	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2004-10-15	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-06-29	STANDARD
LABELING; Labeling	SUPPL	7	AP	2005-08-12	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2006-09-29	STANDARD
LABELING; Labeling	SUPPL	11	AP	2007-01-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2006-12-20	STANDARD
LABELING; Labeling	SUPPL	15	AP	2008-12-16	STANDARD
LABELING; Labeling	SUPPL	17	AP	2009-12-22	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2011-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-09-22	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2012-08-10	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-03-13	PRIORITY
LABELING; Labeling	SUPPL	27	AP	2013-10-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2015-06-19	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2015-12-02	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-12-27	STANDARD
LABELING; Labeling	SUPPL	33	AP	2019-08-15	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	2	Null	41
SUPPL	17	Null	7
SUPPL	20	Null	6
SUPPL	21	Null	0
SUPPL	25	Null	6
SUPPL	26	Null	0
SUPPL	27	Null	15
SUPPL	29	Null	0
SUPPL	30	Null	15
SUPPL	32	Null	33
SUPPL	33	Null	15

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21481
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUZEON","activeIngredients":"ENFUVIRTIDE","strength":"90MG\/VIAL","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/15\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021481s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021481s033lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021481s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021481s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2015","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021481s030lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2013","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021481s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021481s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2011","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021481s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021481s017lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2007","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021481s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2006","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021481s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2006","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021481s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2005","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021481s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021481s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2004","submission":"SUPPL-2","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21481s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021481lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FUZEON","submission":"ENFUVIRTIDE","actionType":"90MG\/VIAL","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-15
        )

)

NDA 021481

ROCHE

FDA Drug Application

Application #021481

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ROCHE