Orange Book product · Brand (NDA)

ASTEPRO ALLERGY

AZELASTINE HYDROCHLORIDE

Brand (NDA)NDA 213872OTC BAYER HLTHCARE

Jun 17, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 17, 2021
5 yr 1 mo ago
Today
Patent 8071073 expires
Listed drug product patent expiration.
Jun 04, 2028
in 2 yr

Active ingredient

AZELASTINE HYDROCHLORIDE

Strength

0.2055MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 213872

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8071073	Jun 04, 2028	in 2 yr	Product