FDA Orange Book
Generic for Dibenzyline
Dibenzyline contains phenoxybenzamine. 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 Dibenzyline is phenoxybenzamine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Dibenzyline products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 5 | AB |
NDA 008708, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic phenoxybenzamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 204522 | AB (A-rated, therapeutically equivalent) | January 24, 2017 | 10MG |
| AMNEAL EU LTD | 212568 | AB (A-rated, therapeutically equivalent) | October 27, 2020 | 10MG |
| NOVITIUM PHARMA LLC | 215042 | AB (A-rated, therapeutically equivalent) | July 19, 2022 | 10MG |
| AUROBINDO PHARMA LTD | 215600 | AB (A-rated, therapeutically equivalent) | May 8, 2023 | 10MG |
| RISING PHARMA HOLDINGS INC | 204551 | AB (A-rated, therapeutically equivalent) | June 20, 2023 | 10MG |
Questions
Is there a generic for Dibenzyline?
Yes. The generic name for Dibenzyline is phenoxybenzamine. 5 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 Dibenzyline?
The active ingredient in Dibenzyline is phenoxybenzamine, 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.