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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021078
Company: GLAXOSMITHKLINE

Products on NDA 021078

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021078

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

Labels for NDA 021078

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

Therapeutic Equivalents for NDA 021078

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 PHARMS LTD
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	250MG;100MG	TABLET;ORAL	Prescription	No	AB	202362	MYLAN
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 PHARMS LTD
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET;ORAL	Prescription	No	AB	202362	MYLAN
MALARONE PEDIATRIC	ATOVAQUONE; PROGUANIL HYDROCHLORIDE	62.5MG;25MG	TABLET;ORAL	Prescription	Yes	AB	021078	GLAXOSMITHKLINE

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