Atovaquone
ATOVAQUONE Oral Suspension 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 Suspension Initial U.S. Approval: 1992
Approved
Approval ID
de0e29b5-a4c7-405c-a5b9-438729d9ba3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-528
Application NumberANDA207833
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atovaquone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2023
FDA Product Classification
INGREDIENTS (6)
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ATOVAQUONEActive
Quantity: 750 mg in 5 mL
Code: Y883P1Z2LT
Classification: ACTIB
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT