| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LANREOTIDE ACETATE | 215395 | 001 | NDA | LANREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | Yes | Yes | 2021/12/17 | 2021/12/17 | INVAGEN PHARMS | Prescription |
| LANREOTIDE ACETATE | 215395 | 002 | NDA | LANREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | Yes | Yes | 2021/12/17 | 2021/12/17 | INVAGEN PHARMS | Prescription |
| LANREOTIDE ACETATE | 215395 | 003 | NDA | LANREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | Yes | Yes | 2021/12/17 | 2021/12/17 | INVAGEN PHARMS | Prescription |
| LANREOTIDE ACETATE | 217193 | 001 | ANDA | LANREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) | No | No | 2024/05/21 | 2024/05/21 | INVAGEN PHARMS | Prescription |
| LANREOTIDE ACETATE | 217193 | 002 | ANDA | LANREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) | No | No | 2024/05/21 | 2024/05/21 | INVAGEN PHARMS | Prescription |
| LANREOTIDE ACETATE | 217193 | 003 | ANDA | LANREOTIDE ACETATE | SOLUTION;SUBCUTANEOUS | EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML) | No | No | 2024/05/21 | 2024/05/21 | INVAGEN PHARMS | Prescription |