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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
SANDOSTATIN | 019667 | 001 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.05MG BASE/ML | Yes | Yes | 1988/10/21 | 1988/10/21 | NOVARTIS | Prescription |
SANDOSTATIN | 019667 | 002 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.1MG BASE/ML | Yes | Yes | 1988/10/21 | 1988/10/21 | NOVARTIS | Prescription |
SANDOSTATIN | 019667 | 003 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.5MG BASE/ML | Yes | Yes | 1988/10/21 | 1988/10/21 | NOVARTIS | Prescription |
SANDOSTATIN | 019667 | 004 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1988/10/21 | 1991/06/12 | NOVARTIS | Discontinued |
SANDOSTATIN | 019667 | 005 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Yes | No | 1988/10/21 | 1991/06/12 | NOVARTIS | Discontinued |
SANDOSTATIN LAR | 021008 | 001 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 10MG BASE/VIAL | Yes | No | 1998/11/25 | 1998/11/25 | NOVARTIS | Prescription |
SANDOSTATIN LAR | 021008 | 002 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 20MG BASE/VIAL | Yes | No | 1998/11/25 | 1998/11/25 | NOVARTIS | Prescription |
SANDOSTATIN LAR | 021008 | 003 | NDA | OCTREOTIDE ACETATE | INJECTABLE;INJECTION | EQ 30MG BASE/VIAL | Yes | Yes | 1998/11/25 | 1998/11/25 | NOVARTIS | Prescription |