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Atovaquone and Proguanil Hydrochloride

These highlights do not include all the information needed to use ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLETS. ATOVAQUONE and PROGUANIL HYDROCHLORIDE tablets, for oral useATOVAQUONE and PROGUANIL HYDROCHLORIDE pediatric tablets, for oral useInitial U.S. Approval: 2000

Approved
Approval ID

57d74d71-8cf8-4b10-9420-22954fae623c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 21, 2019

Manufacturers
FDA

Mylan Pharmaceuticals Inc.

DUNS: 059295980

Products 2

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 Code0378-4160
Application NumberANDA202362
Product Classification
M
Marketing Category
C73584
G
Generic Name
atovaquone and proguanil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2019
FDA Product Classification

INGREDIENTS (14)

ATOVAQUONEActive
Quantity: 62.5 mg in 1 1
Code: Y883P1Z2LT
Classification: ACTIB
PROGUANIL HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: R71Y86M0WT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

atovaquone and proguanil hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0378-4162
Application NumberANDA202362
Product Classification
M
Marketing Category
C73584
G
Generic Name
atovaquone and proguanil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2019
FDA Product Classification

INGREDIENTS (14)

FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ATOVAQUONEActive
Quantity: 250 mg in 1 1
Code: Y883P1Z2LT
Classification: ACTIB
PROGUANIL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: R71Y86M0WT
Classification: ACTIB
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

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