Atovaquone and Proguanil Hydrochloride
Atovaquone and Proguanil Hydrochloride Tablets
Approved
Approval ID
0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Atovaquone and Proguanil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-150
Application NumberANDA091211
Product Classification
M
Marketing Category
C73584
G
Generic Name
Atovaquone and Proguanil Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2012
FDA Product Classification
INGREDIENTS (12)
PROGUANIL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: R71Y86M0WT
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
ATOVAQUONEActive
Quantity: 250 mg in 1 1
Code: Y883P1Z2LT
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT