Orange Book product · Generic (ANDA)
AZELASTINE HYDROCHLORIDE
AZELASTINE HYDROCHLORIDE
At a glance
Nov 08, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 08, 2016
9 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
AZELASTINE HYDROCHLORIDE
Strength
0.05%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 203660
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AZELASTINE HYDROCHLORIDE
- 2021ASTEPRO ALLERGYBrand (NDA)
NDA 213872 · BAYER HLTHCARE
- 2008ASTEPROBrand (NDA)
NDA 022203 · VIATRIS
- 2000OPTIVARBrand (NDA)
NDA 021127 · RISING
- 1996ASTELINBrand (NDA)
NDA 020114 · 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
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.
