Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021078
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MALARONE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET;ORAL Prescription AB Yes Yes
MALARONE PEDIATRIC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/14/2000 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021078_malarone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2019 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021078s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021078Orig1s023ltr.pdf
02/27/2013 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021078Orig1s022ltr.pdf
09/02/2009 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021078s017ltr.pdf
12/18/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s016ltr.pdf
05/07/2008 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021078s014ltr.pdf
12/04/2007 SUPPL-12 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021078s012ltr.pdf
02/27/2005 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf
02/27/2005 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021078s008,009ltr.pdf
11/24/2004 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s007ltr.pdf
12/02/2003 SUPPL-6 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21078se5-006_malarone_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21078se5-006ltr.pdf
05/09/2003 SUPPL-5 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021078_s005_MalaroneTOC.cfm
05/13/2002 SUPPL-4 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s004_MalaroneTOC.cfm
08/02/2002 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21078s3lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078se8-003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s003_MalaroneTOC.cfm
09/03/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21078s002ltr.pdf
02/28/2002 SUPPL-1 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21078s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021078_s001_MalaroneTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/22/2019 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021078s023lbl.pdf
02/27/2013 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021078s022lbl.pdf
12/18/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s016lbl.pdf
05/07/2008 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021078s014lbl.pdf
02/27/2005 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf
02/27/2005 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021078s008,009lbl.pdf
11/24/2004 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s007lbl.pdf
09/03/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21078s002lbl.pdf
12/02/2003 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21078se5-006_malarone_lbl.pdf
08/02/2002 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21078s3lbl.pdf
07/14/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-078_Malarone_Prntlbl.pdf

MALARONE

TABLET;ORAL; 250MG;100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET;ORAL Prescription No AB 091211 GLENMARK GENERICS
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET;ORAL Prescription No AB 202362 MYLAN PHARMS INC
MALARONE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 250MG;100MG TABLET;ORAL Prescription Yes AB 021078 GLAXOSMITHKLINE

MALARONE PEDIATRIC

TABLET;ORAL; 62.5MG;25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET;ORAL Prescription No AB 091211 GLENMARK GENERICS
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET;ORAL Prescription No AB 202362 MYLAN PHARMS INC
MALARONE PEDIATRIC ATOVAQUONE; PROGUANIL HYDROCHLORIDE 62.5MG;25MG TABLET;ORAL Prescription Yes AB 021078 GLAXOSMITHKLINE

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English