MEPRON
These highlights do not include all the information needed to use MEPRON oral suspension safely and effectively. See full prescribing information for MEPRON oral suspension.MEPRON (atovaquone oral suspension)Initial U.S. Approval: 1992
Approved
Approval ID
b426b6bf-f07e-4580-97ae-dfca1ddf5b8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2023
Manufacturers
FDA
GlaxoSmithKline LLC
DUNS: 167380711
Products 2
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 Code0173-0547
Application NumberNDA020500
Product Classification
M
Marketing Category
C73594
G
Generic Name
atovaquone
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2015
FDA Product Classification
INGREDIENTS (6)
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ATOVAQUONEActive
Quantity: 750 mg in 5 mL
Code: Y883P1Z2LT
Classification: ACTIB
atovaquone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0173-0665
Application NumberNDA020500
Product Classification
M
Marketing Category
C73594
G
Generic Name
atovaquone
Product Specifications
Route of AdministrationORAL
Effective DateJune 4, 2015
FDA Product Classification
INGREDIENTS (6)
ATOVAQUONEActive
Quantity: 750 mg in 5 mL
Code: Y883P1Z2LT
Classification: ACTIB
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT