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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/10/2026 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021078s026lbl.pdf | |
| 03/23/2026 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021078s025lbl.pdf | |
| 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 |