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 suspension Initial U.S. Approval: 1992
Approved
Approval ID
ba3cad0d-cce9-424f-ba5c-557dba8bef12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2019
Manufacturers
FDA
Lohxa
DUNS: 079872715
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 Code70166-488
Application NumberANDA210692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atovaquone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2019
FDA Product Classification
INGREDIENTS (7)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ATOVAQUONEActive
Quantity: 750 mg in 5 mL
Code: Y883P1Z2LT
Classification: ACTIB