FDA Orange Book
Generic for Intal
Intal contains cromolyn. 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 Intal is cromolyn. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN. Generics match 1 of the 3 Intal products the Orange Book lists.
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Intal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.8MG/INH | Discontinued | None | 0 | None |
| capsule, inhalation | 20MG | Discontinued | None | 0 | None |
| solution, inhalation | 10MG/ML | Discontinued | None | 4 | AN |
NDA 018887, 016990, 018596, held by KING PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cromolyn
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WOCKHARDT BIO AG | 075346 | AN (A-rated, therapeutically equivalent) | October 25, 1999 | 10MG/ML |
| TEVA PHARMACEUTICALS USA | 075271 | AN (A-rated, therapeutically equivalent) | January 18, 2000 | 10MG/ML |
| SCIEGEN PHARMACEUTICALS INC | 075437 | AN (A-rated, therapeutically equivalent) | April 21, 2000 | 10MG/ML |
| AILEX PHARMACEUTICALS LLC | 209453 | AN (A-rated, therapeutically equivalent) | October 16, 2017 | 10MG/ML |
Questions
Is there a generic for Intal?
Yes. The generic name for Intal is cromolyn. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN. Generics match 1 of the 3 Intal products the Orange Book lists.
What is the generic name for Intal?
The active ingredient in Intal is cromolyn, 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.