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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
DESONIDE | 212473 | 001 | ANDA | DESONIDE | OINTMENT;TOPICAL | 0.05% | No | No | 2019/10/23 | 2019/10/23 | ALEMBIC | Prescription |
DESONIDE | 210198 | 001 | ANDA | DESONIDE | CREAM;TOPICAL | 0.05% | No | No | 2019/11/20 | 2019/11/20 | CADILA | Prescription |
DESONIDE | 202470 | 001 | ANDA | DESONIDE | GEL;TOPICAL | 0.05% | No | Yes | 2020/05/11 | 2020/05/11 | CINTEX SVCS | Prescription |
DESONIDE | 213632 | 001 | ANDA | DESONIDE | LOTION;TOPICAL | 0.05% | No | No | 2020/08/24 | 2020/08/24 | ALEMBIC | Prescription |
BUDESONIDE | 208851 | 001 | ANDA | BUDESONIDE | TABLET, EXTENDED RELEASE;ORAL | 9MG | No | No | 2020/09/17 | 2020/09/17 | MYLAN | Prescription |
BUDESONIDE | 211922 | 001 | ANDA | BUDESONIDE | SUSPENSION;INHALATION | 0.25MG/2ML | No | No | 2021/04/14 | 2021/04/14 | SUN PHARM | Prescription |
BUDESONIDE | 211922 | 002 | ANDA | BUDESONIDE | SUSPENSION;INHALATION | 0.5MG/2ML | No | No | 2021/04/14 | 2021/04/14 | SUN PHARM | Prescription |
BUDESONIDE | 211922 | 003 | ANDA | BUDESONIDE | SUSPENSION;INHALATION | 1MG/2ML | No | No | 2021/04/14 | 2021/04/14 | SUN PHARM | Prescription |
DESONIDE | 214396 | 001 | ANDA | DESONIDE | CREAM;TOPICAL | 0.05% | No | No | 2022/12/08 | 2022/12/08 | ALEMBIC | Prescription |
BUDESONIDE | 215328 | 001 | ANDA | BUDESONIDE | AEROSOL, FOAM;RECTAL | 2MG/ACTUATION | No | Yes | 2023/04/12 | 2023/04/12 | PADAGIS ISRAEL | Prescription |
BUDESONIDE | 216667 | 001 | ANDA | BUDESONIDE | SUSPENSION;INHALATION | 0.5MG/2ML | No | No | 2023/11/29 | 2023/11/29 | EUGIA PHARMA | Discontinued |