FDA Orange Book
Generic for Qualaquin
Qualaquin contains quinine. 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 Qualaquin is quinine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Qualaquin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 324MG | Discontinued | None | 4 | AB |
NDA 021799, held by SUN PHARMACEUTICAL INDUSTRIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic quinine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 091661 | AB (A-rated, therapeutically equivalent) | September 28, 2012 | 324MG |
| LUPIN LTD | 203112 | AB (A-rated, therapeutically equivalent) | April 24, 2015 | 324MG |
| AMNEAL PHARMACEUTICALS | 203729 | AB (A-rated, therapeutically equivalent) | July 15, 2015 | 324MG |
| INGENUS PHARMACEUTICALS LLC | 204372 | AB (A-rated, therapeutically equivalent) | July 22, 2015 | 324MG |
Questions
Is there a generic for Qualaquin?
Yes. The generic name for Qualaquin is quinine. 4 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 Qualaquin?
The active ingredient in Qualaquin is quinine, 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.