Is Astelin still available?

Astelin (NDA 020114) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Astelin have a generic?

Yes. The Orange Book lists 27 approved generic (ANDA) applications sharing Astelin's active ingredient (Azelastine Hydrochloride). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Astelin's FDA application number?

Astelin is approved under NDA 020114, held by Rising.

Orange Book product · Brand (NDA)

Astelin

Azelastine Hydrochloride

Brand (NDA)NDA 020114DiscontinuedRLD Rising

Approved

Nov 01, 1996

Application

Brand (NDA)

TE code

Not listed

Listed patents

Astelin (Azelastine Hydrochloride) is Rising's brand-name drug, approved by the FDA under NDA 020114 in 1996. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 27 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Nov 01, 1996
30 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AZELASTINE HYDROCHLORIDE

Strength

0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 020114

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Azelastine Hydrochloride family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Astelin — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Azelastine Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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