| 商品名 | 申请号 | 产品号 | 申请类型 | 活性成分 | 剂型/给药途径 | 规格/剂量 | RLD | RS | 申请号原始批准/暂定批准日期 | 产品号批准日期 | 申请人 | 市场状态 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE | 210032 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No | 2019/08/23 | 2019/08/23 | SAPTALIS PHARMS | Discontinued |
| AZELASTINE HYDROCHLORIDE | 210092 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SOLUTION/DROPS;OPHTHALMIC | 0.05% | No | No | 2020/02/25 | 2020/02/25 | GLAND PHARMA LTD | Prescription |
| AZELASTINE HYDROCHLORIDE | 212289 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.137MG/SPRAY | No | No | 2020/05/08 | 2020/05/08 | AUROBINDO PHARMA LTD | Prescription |
| AZELASTINE HYDROCHLORIDE | 212775 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No | 2020/11/12 | 2020/11/12 | AUROBINDO PHARMA LTD | Discontinued |
| AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE | 208111 | 001 | ANDA | AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE | SPRAY, METERED;NASAL | 0.137MG/SPRAY;0.05MG/SPRAY | No | No | 2021/02/18 | 2021/02/18 | PADAGIS ISRAEL | Prescription |
| AZELASTINE HYDROCHLORIDE | 216561 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY;NASAL | 205.5MCG | No | No | 2023/11/29 (TA) | -- | AUROBINDO PHARMA LTD | None (Tentative Approval) |
| AZELASTINE HYDROCHLORIDE | 216801 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No | 2024/05/08 | 2024/05/08 | PADAGIS ISRAEL | Discontinued |
| AZELASTINE HYDROCHLORIDE ALLERGY | 216421 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No | 2024/05/29 | 2024/05/29 | APOTEX | Over-the-counter |
| AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 216421 | 002 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No | 2024/05/29 | 2024/05/29 | APOTEX | Over-the-counter |
| AZELASTINE HYDROCHLORIDE | 216576 | 001 | ANDA | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No | 2024/06/05 | 2024/06/05 | AMNEAL | Over-the-counter |