Atovaquone
These highlights do not include all the information needed to use ATOVAQUONE ORAL SUSPENSION safely and effectively. See full prescribing information for ATOVAQUONE ORAL SUSPENSION. ATOVAQUONE oral suspensionInitial U.S. Approval: 1992
Approved
Approval ID
c61aa490-5b55-4ba9-b107-bb37f1fa352b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2023
Manufacturers
FDA
VistaPharm, LLC
DUNS: 116743084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atovaquone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66689-062
Application NumberANDA202960
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atovaquone
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 24, 2023
FDA Product Classification
INGREDIENTS (9)
ATOVAQUONEActive
Quantity: 750 mg in 5 mL
Code: Y883P1Z2LT
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT