Atovaquone

Basic Information

Product Name

Atovaquone

FDA Product Code

66689-062

Regulatory Information

NDC Product Code

66689-062

Application Number

ANDA202960

Marketing Category

C73584

Effective Date

February 24, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ATOVAQUONE

Quantity: 750 mg in 5 mL

Code: Y883P1Z2LT

Class Code: ACTIB

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

POLOXAMER 188

Code: LQA7B6G8JG

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

Code: Y883P1Z2LT

Atovaquone

Basic Information

Regulatory Information

Company Information

Active Ingredients

BENZYL ALCOHOL

WATER

SACCHARIN SODIUM

POLOXAMER 188

XANTHAN GUM

ALCOHOL

TRIACETIN

PROPYLENE GLYCOL

Active Moieties

ATOVAQUONE