NDA 020500

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #020500

Documents

• Letter: 2008-05-09
• Letter: 2015-06-10
• Label: 2004-06-09
• Label: 2013-03-05
• Label: 2015-06-10
• Letter: 2004-06-09
• Letter: 2013-03-04
• Label: 2008-05-12
• Review: 2004-06-09
• Label: 2017-10-17
• Letter: 2017-10-18
• Letter: 2019-02-27
• Label: 2019-03-04
• Label: 2019-07-19
• Letter: 2019-07-19

Application Sponsors

NDA 020500

GLAXOSMITHKLINE LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

750MG/5ML

1

MEPRON

ATOVAQUONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-02-08	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1997-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-08-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-09-14	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	1999-01-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2008-05-07	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-03-01	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-06-04	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-10-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-02-22	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-07-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	14	Null	6
SUPPL	15	Null	6
SUPPL	16	Null	7
SUPPL	17	Null	33
SUPPL	19	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GLAXOSMITHKLINE LLC

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(
    [0] => Array
        (
            [ApplNo] => 20500
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPRON","activeIngredients":"ATOVAQUONE","strength":"750MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/18\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020500s019lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020500s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/20500s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/20500s016lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020500s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020500s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2008","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020500s010lbl.pdf\"}]","notes":""},{"actionDate":"01\/05\/1999","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20-500-S005.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MEPRON","submission":"ATOVAQUONE","actionType":"750MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-18
        )

)