FDA Orange Book

Is there a generic for Cysto-Conray II?

Cysto-Conray II contains iothalamate. 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 Cysto-Conray II (iothalamate).

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Cysto-Conray II products in the Orange Book

Cysto-Conray II products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravesical17.2%Marketed (Rx)None0None

NDA 017057, held by LIEBEL-FLARSHEIM CO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Cysto-Conray II NDC codes

Questions

Is there a generic for Cysto-Conray II?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Cysto-Conray II (iothalamate).

What is the generic name for Cysto-Conray II?

The active ingredient in Cysto-Conray II is iothalamate, 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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