| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PITOCIN | 018261 | 001 | NDA | OXYTOCIN | INJECTABLE;INJECTION | 10USP UNITS/ML (10USP UNITS/ML) | Yes | Yes | 1980/11/19 | Approved Prior to Jan 1, 1982 | ENDO OPERATIONS | Prescription |
| PITOCIN | 018261 | 002 | NDA | OXYTOCIN | INJECTABLE;INJECTION | 100USP UNITS/10ML (10USP UNITS/ML) | Yes | No | 1980/11/19 | 2007/07/27 | ENDO OPERATIONS | Prescription |
| PITOCIN | 018261 | 003 | NDA | OXYTOCIN | INJECTABLE;INJECTION | 500USP UNITS/50ML (10USP UNITS/ML) | Yes | No | 1980/11/19 | 2012/09/05 | ENDO OPERATIONS | Prescription |