FDA Orange Book
Is there a generic for Gleolan?
Gleolan contains aminolevulinic acid. 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 Gleolan (aminolevulinic acid).
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Gleolan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 1.5GM/VIAL | Marketed (Rx) | None | 0 | None |
NDA 208630, held by NX DEVELOPMENT CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gleolan NDC codes
Questions
Is there a generic for Gleolan?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gleolan (aminolevulinic acid).
What is the generic name for Gleolan?
The active ingredient in Gleolan is aminolevulinic acid, 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.