FDA Orange Book
Is there a generic for Myleran?
Myleran contains busulfan. 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 Myleran (busulfan).
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Myleran products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 2MG | Marketed (Rx) | None | 0 | None |
NDA 009386, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Myleran NDC codes
Questions
Is there a generic for Myleran?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Myleran (busulfan).
What is the generic name for Myleran?
The active ingredient in Myleran is busulfan, 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.