FDA Orange Book
Generic for Malarone Pediatric
Malarone Pediatric contains atovaquone and proguanil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Malarone Pediatric is atovaquone and proguanil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Malarone Pediatric products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 62.5MG;25MG | Marketed (Rx) | AB | 2 | AB |
NDA 021078, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic atovaquone and proguanil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 202362 | AB (A-rated, therapeutically equivalent) | May 27, 2014 | 62.5MG;25MG |
| GLENMARK PHARMACEUTICALS LTD | 091211 | AB (A-rated, therapeutically equivalent) | April 6, 2015 | 62.5MG;25MG |
Malarone Pediatric NDC codes
Questions
Is there a generic for Malarone Pediatric?
Yes. The generic name for Malarone Pediatric is atovaquone and proguanil. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Malarone Pediatric?
The active ingredient in Malarone Pediatric is atovaquone and proguanil, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.