FDA Orange Book

Is there a generic for Aridol Kit?

Aridol Kit contains mannitol. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Aridol Kit (mannitol).

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Aridol Kit products in the Orange Book

Aridol Kit products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, inhalationN/A,5MG,10MG,20MG,40MGMarketed (Rx)None0None

NDA 022368, held by PHARMAXIS EUROPE LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Questions

Is there a generic for Aridol Kit?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Aridol Kit (mannitol).

What is the generic name for Aridol Kit?

The active ingredient in Aridol Kit is mannitol, 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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