FDA Orange Book
Generic for Navane
Navane contains thiothixene. 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 Navane is thiothixene. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Navane products the Orange Book lists.
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Navane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 3 | AB |
| capsule, oral | 1MG | Discontinued | None | 3 | AB |
| capsule, oral | 20MG | Discontinued | None | 0 | None |
| capsule, oral | 2MG | Discontinued | None | 3 | AB |
| capsule, oral | 5MG | Discontinued | None | 3 | AB |
| concentrate, oral | EQ 5MG BASE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 10MG BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 2MG BASE/ML | Discontinued | None | 0 | None |
NDA 016584, 016758, 016904, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic thiothixene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 071093 | AB (A-rated, therapeutically equivalent) | June 23, 1987 | 10MG, 1MG, 2MG, 5MG |
| NOVITIUM PHARMA LLC | 211642 | AB (A-rated, therapeutically equivalent) | April 5, 2019 | 10MG, 1MG, 2MG, 5MG |
| AMNEAL EU LTD | 215456 | AB (A-rated, therapeutically equivalent) | February 28, 2022 | 10MG, 1MG, 2MG, 5MG |
Questions
Is there a generic for Navane?
Yes. The generic name for Navane is thiothixene. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Navane products the Orange Book lists.
What is the generic name for Navane?
The active ingredient in Navane is thiothixene, 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.