FDA Orange Book
Generic for Astelin
Astelin contains azelastine. 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 Astelin is azelastine. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Astelin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | 0.137MG/SPRAY | Discontinued | None | 6 | AB |
NDA 020114, held by RISING PHARMA HOLDINGS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic azelastine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 077954 | AB (A-rated, therapeutically equivalent) | April 30, 2009 | 0.137MG/SPRAY |
| ZYDUS PHARMACEUTICALS USA INC | 091409 | AB (A-rated, therapeutically equivalent) | August 14, 2017 | 0.137MG/SPRAY |
| ALKEM LABORATORIES LTD | 208156 | AB (A-rated, therapeutically equivalent) | August 18, 2017 | 0.137MG/SPRAY |
| AMNEAL PHARMACEUTICALS LLC | 204660 | AB (A-rated, therapeutically equivalent) | August 28, 2017 | 0.137MG/SPRAY |
| EPIC PHARMA LLC | 207610 | AB (A-rated, therapeutically equivalent) | May 17, 2019 | 0.137MG/SPRAY |
| AUROBINDO PHARMA LTD | 212289 | AB (A-rated, therapeutically equivalent) | May 8, 2020 | 0.137MG/SPRAY |
Questions
Is there a generic for Astelin?
Yes. The generic name for Astelin is azelastine. 6 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 Astelin?
The active ingredient in Astelin is azelastine, 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.