MALARONE - atovaquone and proguanil hydrochloride
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Field |
Value |
NDC Code: |
55289-747 |
Proprietary Name: |
MALARONE |
Suffix: |
|
Non-Proprietary Name: |
atovaquone and proguanil hydrochloride |
Dosage Form: |
TABLET, FILM COATED |
Method: |
ORAL |
Original Marketing Date: |
26-07-2000 |
Category Name: |
NDA |
Application Number: |
NDA021078 |
Labeler: |
PD RX PHARMACEUTICALS, INC. |
Substance Name: |
ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
Active Numerator Strength: |
250; 100 |
Active Ingredient Unit: |
mg/1; mg/1 |
Pharm Classes: |
Antimalarial [EPC],Antiprotozoal [EPC],Antimalarial [EPC],Dihydrofolate Reductase Inhibitors [MoA] |
DEA Schedule: |
|