| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FINGOLIMOD | 207965 | 001 | ANDA | FINGOLIMOD | CAPSULE;ORAL | 0.5MG | No | No | 2017/03/22 (TA) | -- | PAR PHARM INC | None (Tentative Approval) |
| FINGOLIMOD HYDROCHLORIDE | 207979 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2019/12/04 | 2019/12/04 | BIOCON LTD | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 208014 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2019/12/04 | 2019/12/04 | SUN PHARM | Discontinued |
| FINGOLIMOD HYDROCHLORIDE | 207933 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/05/18 | 2020/05/18 | HETERO LABS LTD V | Prescription |
| FINGOLIMOD | 208559 | 001 | ANDA | FINGOLIMOD | CAPSULE;ORAL | 0.5MG | No | No | 2020/05/20 (TA) | -- | MSN LABS PVT LTD | None (Tentative Approval) |
| FINGOLIMOD HYDROCHLORIDE | 207985 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/06/18 | 2020/06/18 | GLENMARK PHARMS LTD | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 207971 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/06/29 | 2020/06/29 | CHARTWELL RX | Discontinued |
| FINGOLIMOD HYDROCHLORIDE | 208008 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/07/02 | 2020/07/02 | TEVA PHARMS USA | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 207994 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/10/14 | 2020/10/14 | ZYDUS PHARMS | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 207991 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/10/28 | 2020/10/28 | ACCORD HLTHCARE | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 207993 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/12/18 | 2020/12/18 | APOTEX | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 208004 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2020/12/30 | 2020/12/30 | ALKEM LABS LTD | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 208005 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2021/01/19 | 2021/01/19 | MYLAN | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 208000 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2021/03/05 | 2021/03/05 | DR REDDYS | Prescription |
| FINGOLIMOD | 207940 | 001 | ANDA | FINGOLIMOD | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2021/05/11 (TA) | -- | STANDARD CHEM AND PHARM CO LTD | None (Tentative Approval) |
| FINGOLIMOD HYDROCHLORIDE | 207939 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2021/11/10 | 2021/11/10 | HEC PHARM CO LTD | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 212152 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.25MG BASE | No | No | 2021/11/12 | 2021/11/12 | TEVA PHARMS USA | Discontinued |
| FINGOLIMOD HYDROCHLORIDE | 208003 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2022/09/07 | 2022/09/07 | PRINSTON INC | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 210252 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2023/05/24 | 2023/05/24 | BIONPHARMA | Prescription |
| FINGOLIMOD HYDROCHLORIDE | 207945 | 001 | ANDA | FINGOLIMOD HYDROCHLORIDE | CAPSULE;ORAL | EQ 0.5MG BASE | No | No | 2023/12/06 | 2023/12/06 | EZRA VENTURES | Prescription |