Documents
Application Sponsors
| NDA 021078 | GLAXOSMITHKLINE | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | 250MG;100MG | 1 | MALARONE | ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
| 002 | TABLET;ORAL | 62.5MG;25MG | 1 | MALARONE PEDIATRIC | ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2000-07-14 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2004-09-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2002-08-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-05-13 | PRIORITY |
| S; Supplement | SUPPL | 5 | AP | 2003-05-09 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2003-12-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2004-11-24 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2005-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2005-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2007-12-04 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2008-05-07 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2008-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2009-09-02 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2013-02-27 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-02-22 | STANDARD |
Submissions Property Types
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 8 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 31 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 21078
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"MALARONE","activeIngredients":"ATOVAQUONE; PROGUANIL HYDROCHLORIDE","strength":"250MG;100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"MALARONE PEDIATRIC","activeIngredients":"ATOVAQUONE; PROGUANIL HYDROCHLORIDE","strength":"62.5MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"02\/22\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021078s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2013","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021078s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021078s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/07\/2008","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021078s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2005","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021078s008,009lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021078s008,009lbl.pdf\"}]","notes":""},{"actionDate":"11\/24\/2004","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21078s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2004","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21078s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/02\/2003","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21078se5-006_malarone_lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2002","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21078s3lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/21-078_Malarone_Prntlbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"MALARONE","submission":"ATOVAQUONE; PROGUANIL HYDROCHLORIDE","actionType":"250MG;100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"MALARONE PEDIATRIC","submission":"ATOVAQUONE; PROGUANIL HYDROCHLORIDE","actionType":"62.5MG;25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-02-22
)
)