FDA Orange Book
Generic for Symbyax
Symbyax contains olanzapine and fluoxetine. 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 Symbyax is olanzapine and fluoxetine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Symbyax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 25MG BASE;EQ 12MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 25MG BASE;EQ 3MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 25MG BASE;EQ 6MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 50MG BASE;EQ 12MG BASE | Discontinued | None | 3 | AB |
| capsule, oral | EQ 50MG BASE;EQ 6MG BASE | Discontinued | None | 3 | AB |
NDA 021520, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic olanzapine and fluoxetine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 077528 | AB (A-rated, therapeutically equivalent) | June 19, 2012 | EQ 25MG BASE;EQ 12MG BASE, EQ 25MG BASE;EQ 6MG BASE, EQ 50MG BASE;EQ 12MG BASE, EQ 50MG BASE;EQ 6MG BASE |
| PH HEALTH LTD | 077742 | AB (A-rated, therapeutically equivalent) | November 2, 2012 | EQ 25MG BASE;EQ 12MG BASE, EQ 25MG BASE;EQ 3MG BASE, EQ 25MG BASE;EQ 6MG BASE, EQ 50MG BASE;EQ 12MG BASE, EQ 50MG BASE;EQ 6MG BASE |
| EPIC PHARMA LLC | 078901 | AB (A-rated, therapeutically equivalent) | November 16, 2012 | EQ 25MG BASE;EQ 12MG BASE, EQ 25MG BASE;EQ 3MG BASE, EQ 25MG BASE;EQ 6MG BASE, EQ 50MG BASE;EQ 12MG BASE, EQ 50MG BASE;EQ 6MG BASE |
| TEVA PHARMACEUTICALS USA | 202074 | AB (A-rated, therapeutically equivalent) | March 25, 2013 | EQ 25MG BASE;EQ 3MG BASE |
Questions
Is there a generic for Symbyax?
Yes. The generic name for Symbyax is olanzapine and fluoxetine. 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 Symbyax?
The active ingredient in Symbyax is olanzapine and fluoxetine, 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.