FDA Orange Book
Generic for Haldol Solutab
Haldol Solutab contains haloperidol. 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 Haldol Solutab is haloperidol. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Haldol Solutab products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 1MG | Discontinued | None | 12 | AB |
NDA 017079, held by ORTHO MCNEIL PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic haloperidol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 070278 | AB (A-rated, therapeutically equivalent) | June 10, 1986 | 1MG |
| CHARTWELL RX SCIENCES LLC | 071209 | AB (A-rated, therapeutically equivalent) | November 17, 1986 | 1MG |
| SCIEGEN PHARMACEUTICALS INC | 071173 | AB (A-rated, therapeutically equivalent) | January 2, 1987 | 1MG |
| APPCO PHARMA LLC | 211061 | AB (A-rated, therapeutically equivalent) | January 8, 2020 | 1MG |
| MSN LABORATORIES PRIVATE LTD | 216004 | AB (A-rated, therapeutically equivalent) | November 18, 2022 | 1MG |
| ZYDUS PHARMACEUTICALS USA INC | 077580 | AB (A-rated, therapeutically equivalent) | January 17, 2023 | 1MG |
| MANKIND PHARMA LTD | 216918 | AB (A-rated, therapeutically equivalent) | April 11, 2024 | 1MG |
| AUROBINDO PHARMA LTD | 218789 | AB (A-rated, therapeutically equivalent) | April 19, 2024 | 1MG |
| CREEKWOOD PHARMACEUTICALS LLC | 218162 | AB (A-rated, therapeutically equivalent) | December 18, 2025 | 1MG |
| AIPING PHARMACEUTICAL INC | 071130 | AB (A-rated, therapeutically equivalent) | April 8, 2026 | 1MG |
| ALEMBIC PHARMACEUTICALS LTD | 214470 | AB (A-rated, therapeutically equivalent) | June 4, 2026 | 1MG |
| AJANTA PHARMA LTD | 218210 | AB (A-rated, therapeutically equivalent) | September 14, 2026 | 1MG |
Questions
Is there a generic for Haldol Solutab?
Yes. The generic name for Haldol Solutab is haloperidol. 12 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 Haldol Solutab?
The active ingredient in Haldol Solutab is haloperidol, 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.