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FDA Approval

Atovaquone and Proguanil HCl

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 23, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Atovaquone(250 mg in 1 1)
Proguanil(100 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Atovaquone and Proguanil HCl

Product Details

NDC Product Code
50090-2980
Application Number
NDA021078
Marketing Category
NDA authorized generic (C73605)
Route of Administration
ORAL
Effective Date
February 2, 2021
Code: Y883P1Z2LTClass: ACTIBQuantity: 250 mg in 1 1
ProguanilActive
Code: R71Y86M0WTClass: ACTIBQuantity: 100 mg in 1 1
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JGClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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