FDA Orange Book · active-ingredient family
Azelastine hydrochloride
Azelastine hydrochloride is approved as 4 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ASTEPRO ALLERGY · NDA 213872
4
Brand (NDA)
27
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ASTEPRO ALLERGYRLD×2 | BAYER HLTHCARE | NDA 213872 | — | Jun 17, 2021 | |
| ASTEPRORLD×2 | VIATRIS | NDA 022203 | — | Oct 15, 2008 | |
| OPTIVARRLD | RISING | NDA 021127 | — | May 22, 2000 | |
| ASTELINRLD | RISING | NDA 020114 | — | Nov 01, 1996 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE ALLERGY | AUROBINDO PHARMA | ANDA 216561 | — | Jan 27, 2025 | |
| AZELASTINE HYDROCHLORIDE | AMNEAL | ANDA 216576 | — | Jun 05, 2024 | |
| AZELASTINE HYDROCHLORIDE ALLERGY×2 | APOTEX | ANDA 216421 | — | May 29, 2024 | |
| AZELASTINE HYDROCHLORIDE | PADAGIS ISRAEL | ANDA 216801 | — | May 08, 2024 | |
| AZELASTINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 212775 | — | Nov 12, 2020 | |
| AZELASTINE HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 212289 | AB | May 08, 2020 | |
| AZELASTINE HYDROCHLORIDE | GLAND | ANDA 210092 | AT | Feb 25, 2020 | |
| AZELASTINE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 210032 | — | Aug 23, 2019 | |
| AZELASTINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 207610 | AB | May 17, 2019 | |
| AZELASTINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 207411 | AT | Mar 29, 2019 | |
| AZELASTINE HYDROCHLORIDE | ALEMBIC | ANDA 209620 | AT | Mar 20, 2019 | |
| AZELASTINE HYDROCHLORIDE | AMNEAL | ANDA 208199 | — | Dec 15, 2017 | |
| AZELASTINE HYDROCHLORIDE | HIKMA | ANDA 207243 | — | Sep 22, 2017 | |
| AZELASTINE HYDROCHLORIDE | AMNEAL | ANDA 204660 | AB | Aug 28, 2017 | |
| AZELASTINE HYDROCHLORIDE | ALKEM LABS LTD | ANDA 208156 | AB | Aug 18, 2017 | |
| AZELASTINE HYDROCHLORIDE | ZYDUS PHARMS | ANDA 091409 | AB | Aug 14, 2017 | |
| AZELASTINE HYDROCHLORIDE | PADAGIS US | ANDA 202609 | — | Mar 17, 2017 | |
| AZELASTINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 203660 | — | Nov 08, 2016 | |
| AZELASTINE HYDROCHLORIDE | BIONPHARMA | ANDA 090176 | — | Jul 28, 2015 | |
| AZELASTINE HYDROCHLORIDE | HIKMA | ANDA 091444 | — | Oct 24, 2014 | |
| AZELASTINE HYDROCHLORIDE | PADAGIS ISRAEL | ANDA 202743 | — | May 08, 2014 | |
| AZELASTINE HYDROCHLORIDE | APOTEX INC | ANDA 201846 | — | Aug 31, 2012 | |
| AZELASTINE HYDROCHLORIDE | SANDOZ | ANDA 202305 | AT | May 31, 2012 | |
| AZELASTINE HYDROCHLORIDE | SUN PHARM | ANDA 090423 | — | May 23, 2012 | |
| AZELASTINE HYDROCHLORIDE | SUN PHARM | ANDA 078738 | — | Jun 21, 2010 | |
| AZELASTINE HYDROCHLORIDE | APOTEX | ANDA 078621 | AT | Aug 03, 2009 | |
| AZELASTINE HYDROCHLORIDE | APOTEX INC | ANDA 077954 | AB | Apr 30, 2009 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071073 | Jun 04, 2028 | in 2 yr | Product |
Azelastine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
