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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | 064021 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No | 1994/05/31 | 1994/05/31 | APOTHECON | Discontinued |
TOBRAMYCIN SULFATE | 064021 | 002 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 1994/05/31 | 1994/05/31 | APOTHECON | Discontinued |
TOBRAMYCIN SULFATE | 063119 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No | 1994/10/31 | 1994/10/31 | IGI LABS INC | Discontinued |
TOBRAMYCIN SULFATE | 065013 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | Yes | 2001/08/17 | 2001/08/17 | XGEN PHARMS | Prescription |
TOBRAMYCIN SULFATE (PHARMACY BULK) | 065120 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | Yes | 2002/11/29 | 2002/11/29 | FRESENIUS KABI USA | Prescription |
TOBRAMYCIN SULFATE | 065122 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | Yes | 2002/11/29 | 2002/11/29 | FRESENIUS KABI USA | Prescription |
TOBRAMYCIN SULFATE | 065122 | 002 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | Yes | 2002/11/29 | 2002/11/29 | FRESENIUS KABI USA | Prescription |
TOBRAMYCIN SULFATE | 050789 | 001 | NDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | No | 2004/07/13 | 2004/07/13 | FRESENIUS KABI USA | Prescription |
TOBRAMYCIN SULFATE | 065407 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 2008/03/11 | 2008/03/11 | MYLAN LABS LTD | Prescription |
TOBRAMYCIN SULFATE | 205179 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 2014/09/16 | 2014/09/16 | EPIC PHARMA LLC | Discontinued |
TOBRAMYCIN SULFATE | 205685 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | No | 2014/09/16 | 2014/09/16 | XELLIA PHARMS APS | Prescription |
TOBRAMYCIN SULFATE | 206965 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 2016/07/01 | 2016/07/01 | BAXTER HLTHCARE CORP | Prescription |
TOBRAMYCIN SULFATE (PHARMACY BULK) | 209346 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 2021/02/09 | 2021/02/09 | GLAND PHARMA LTD | Prescription |
TOBRAMYCIN SULFATE | 209621 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No | 2021/02/11 | 2021/02/11 | GLAND PHARMA LTD | Prescription |
TOBRAMYCIN SULFATE | 209621 | 002 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 2021/02/11 | 2021/02/11 | GLAND PHARMA LTD | Prescription |
TOBRAMYCIN SULFATE | 211189 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | No | 2021/05/18 | 2021/05/18 | GLAND PHARMA LTD | Prescription |
TOBRAMYCIN SULFATE | 217029 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | No | 2023/02/01 | 2023/02/01 | SLATE RUN PHARMA | Prescription |
TOBRAMYCIN SULFATE | 217519 | 001 | ANDA | TOBRAMYCIN SULFATE | INJECTABLE;INJECTION | EQ 1.2GM BASE/VIAL | No | No | 2023/06/21 | 2023/06/21 | EUGIA PHARMA | Prescription |