FDA Orange Book
Generic for Delzicol
Delzicol contains mesalamine. 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 Delzicol is mesalamine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Delzicol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | 400MG | Discontinued | None | 1 | None |
NDA 204412, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mesalamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 207873 | None (No TE code listed) | May 9, 2019 | 400MG |
Questions
Is there a generic for Delzicol?
Yes. The generic name for Delzicol is mesalamine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Delzicol?
The active ingredient in Delzicol is mesalamine, 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.