NDA 021039

GLAXOSMITHKLINE

FDA Drug Application

Application #021039

Documents

• Letter: 1999-04-15
• Letter: 2002-02-05
• Letter: 2002-10-02
• Letter: 2004-03-02
• Label: 1999-04-15
• Label: 2001-05-11
• Label: 2002-08-02
• Label: 2002-10-02
• Label: 2004-04-05
• Review: 2004-05-26
• Review: 2004-05-26
• Letter: 2001-05-11
• Letter: 2002-02-05
• Letter: 2002-08-02
• Letter: 2002-10-02
• Letter: 2005-11-18
• Label: 2002-10-02
• Label: 2005-11-08

Application Sponsors

NDA 021039

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

AGENERASE

AMPRENAVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1999-04-15
LABELING; Labeling	SUPPL	2	AP	2000-04-28
LABELING; Labeling	SUPPL	3	AP	2000-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-12-22
LABELING; Labeling	SUPPL	5	AP	2000-12-19
EFFICACY; Efficacy	SUPPL	6	AP	2001-05-11
LABELING; Labeling	SUPPL	8	AP	2001-05-09
EFFICACY; Efficacy	SUPPL	9	AP	2002-02-05
LABELING; Labeling	SUPPL	10	AP	2002-08-02
LABELING; Labeling	SUPPL	12	AP	2002-02-05
LABELING; Labeling	SUPPL	13	AP	2002-10-02
LABELING; Labeling	SUPPL	14	AP	2002-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-12-24
LABELING; Labeling	SUPPL	16	AP	2004-02-12
LABELING; Labeling	SUPPL	17	AP	2005-11-04

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21039
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AGENERASE","activeIngredients":"AMPRENAVIR","strength":"15MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/04\/2005","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021039s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/12\/2004","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21007slr016,21039slr016_agenerase_lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2002","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21007s14s15,21039s13s14lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2002","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21007s14s15,21039s13s14lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2002","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21007s11,21039s10lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2001","submission":"SUPPL-6","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/N21-007SE7006_Agenerase_Prntlbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/21-007_Agenerase_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AGENERASE","submission":"AMPRENAVIR","actionType":"15MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2005-11-04
        )

)