FDA Orange Book
Generic for Azulfidine En-tabs
Azulfidine En-tabs contains sulfasalazine. 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 Azulfidine En-tabs is sulfasalazine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Azulfidine En-tabs products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 500MG | Marketed (Rx) | AB | 1 | AB |
NDA 007073, 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 sulfasalazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NUVO PHAMACEUTICALS INC | 075339 | AB (A-rated, therapeutically equivalent) | January 11, 2002 | 500MG |
Azulfidine En-tabs NDC codes
Questions
Is there a generic for Azulfidine En-tabs?
Yes. The generic name for Azulfidine En-tabs is sulfasalazine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Azulfidine En-tabs?
The active ingredient in Azulfidine En-tabs is sulfasalazine, 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.