FDA Orange Book

Generic for Quixin

Quixin contains levofloxacin. 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 Quixin is levofloxacin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.

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Quixin products in the Orange Book

Quixin products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution/drops, ophthalmic0.5%DiscontinuedNone2AT

NDA 021199, held by SANTEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic levofloxacin

Approved generic versions of Quixin
CompanyANDATE codeApprovedStrengths
RISING PHARMA HOLDINGS INC077700AT (A-rated, therapeutically equivalent)December 20, 20100.5%
RUBICON RESEARCH LTD078282AT (A-rated, therapeutically equivalent)December 20, 20100.5%

Questions

Is there a generic for Quixin?

Yes. The generic name for Quixin is levofloxacin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.

What is the generic name for Quixin?

The active ingredient in Quixin is levofloxacin, 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.

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