| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | 217334 | 001 | ANDA | ESTRADIOL | TABLET;ORAL | 0.5MG | No | No | 2023/09/06 | 2023/09/06 | NOVITIUM PHARMA | Prescription |
| ESTRADIOL | 217334 | 002 | ANDA | ESTRADIOL | TABLET;ORAL | 1MG | No | No | 2023/09/06 | 2023/09/06 | NOVITIUM PHARMA | Prescription |
| ESTRADIOL | 217334 | 003 | ANDA | ESTRADIOL | TABLET;ORAL | 2MG | No | No | 2023/09/06 | 2023/09/06 | NOVITIUM PHARMA | Prescription |
| ETHINYL ESTRADIOL AND NORELGESTROMIN | 214594 | 001 | ANDA | ETHINYL ESTRADIOL; NORELGESTROMIN | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.035MG/24HR;0.15MG/24HR | No | No | 2023/09/14 | 2023/09/14 | ZYDUS NOVELTECH INC | Prescription |
| ESTRADIOL | 216524 | 001 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.25GM/PACKET) | No | No | 2023/11/14 | 2023/11/14 | PADAGIS ISRAEL | Prescription |
| ESTRADIOL | 216524 | 002 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.5GM/PACKET) | No | No | 2023/11/14 | 2023/11/14 | PADAGIS ISRAEL | Prescription |
| ESTRADIOL | 216524 | 003 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.75GM/PACKET) | No | No | 2023/11/14 | 2023/11/14 | PADAGIS ISRAEL | Prescription |
| ESTRADIOL | 216524 | 004 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1GM/PACKET) | No | No | 2023/11/14 | 2023/11/14 | PADAGIS ISRAEL | Prescription |
| ESTRADIOL | 216524 | 005 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1.25GM/PACKET) | No | No | 2023/11/14 | 2023/11/14 | PADAGIS ISRAEL | Prescription |
| ESTRADIOL | 216160 | 001 | ANDA | ESTRADIOL | GEL, METERED;TRANSDERMAL | 0.06% (1.25GM/ACTIVATION) | No | No | 2024/04/22 | 2024/04/22 | SOLARIS PHARMA CORP | Prescription |
| ESTRADIOL | 216055 | 001 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.25GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | AMNEAL | Prescription |
| ESTRADIOL | 216055 | 002 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.5GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | AMNEAL | Prescription |
| ESTRADIOL | 216055 | 003 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.75GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | AMNEAL | Prescription |
| ESTRADIOL | 216055 | 004 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | AMNEAL | Prescription |
| ESTRADIOL | 216055 | 005 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1.25GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | AMNEAL | Prescription |
| ESTRADIOL | 217863 | 001 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.25GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | SOLARIS PHARMA CORP | Prescription |
| ESTRADIOL | 217863 | 002 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.5GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | SOLARIS PHARMA CORP | Prescription |
| ESTRADIOL | 217863 | 003 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (0.75GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | SOLARIS PHARMA CORP | Prescription |
| ESTRADIOL | 217863 | 004 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | SOLARIS PHARMA CORP | Prescription |
| ESTRADIOL | 217863 | 005 | ANDA | ESTRADIOL | GEL;TRANSDERMAL | 0.1% (1.25GM/PACKET) | No | No | 2024/07/12 | 2024/07/12 | SOLARIS PHARMA CORP | Prescription |