FDA Orange Book
Generic for Zavesca
Zavesca contains miglustat. 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 Zavesca is miglustat. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Zavesca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Marketed (Rx) | AB | 3 | AB |
NDA 021348, held by ACTELION PHARMACEUTICALS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic miglustat
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 208342 | AB (A-rated, therapeutically equivalent) | April 17, 2018 | 100MG |
| EDENBRIDGE PHARMACEUTICALS LLC | 209821 | AB (A-rated, therapeutically equivalent) | August 6, 2020 | 100MG |
| NAVINTA LLC | 219111 | AB (A-rated, therapeutically equivalent) | March 14, 2025 | 100MG |
Zavesca NDC codes
Questions
Is there a generic for Zavesca?
Yes. The generic name for Zavesca is miglustat. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Zavesca?
The active ingredient in Zavesca is miglustat, 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.