Orange Book product · Brand (NDA)
ASTELIN
AZELASTINE HYDROCHLORIDE
At a glance
Nov 01, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 1996
30 yr 1 mo ago
Today
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0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021ASTEPRO ALLERGYBrand (NDA)
NDA 213872 · BAYER HLTHCARE
- 2008ASTEPROBrand (NDA)
NDA 022203 · VIATRIS
- 2000OPTIVARBrand (NDA)
NDA 021127 · RISING
- 2025AZELASTINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 216561 · AUROBINDO PHARMA
- 2024AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216576 · AMNEAL
- 2024AZELASTINE HYDROCHLORIDE ALLERGYGeneric (ANDA)
ANDA 216421 · APOTEX
- 2024AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216801 · PADAGIS ISRAEL
- 2020AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212775 · AUROBINDO PHARMA LTD
- 2020AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212289 · AUROBINDO PHARMA LTD
- 2020AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210092 · GLAND
- 2019AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210032 · SCIEGEN PHARMS
- 2019AZELASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207610 · EPIC PHARMA LLC
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.
