Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021078
Company: GLAXOSMITHKLINE
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 |
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 |
MALARONE PEDIATRIC | ATOVAQUONE; PROGUANIL HYDROCHLORIDE | 62.5MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 021078 | GLAXOSMITHKLINE |