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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 062814 | 010 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 70MG BASE/100ML | No | No | 1987/08/28 | 1987/08/28 | B BRAUN | Discontinued |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 062814 | 011 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 80MG BASE/100ML | No | No | 1987/08/28 | 1987/08/28 | B BRAUN | Discontinued |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 062814 | 012 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 90MG BASE/100ML | No | No | 1987/08/28 | 1987/08/28 | B BRAUN | Discontinued |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 062814 | 013 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 100MG BASE/100ML | No | No | 1987/08/28 | 1987/08/28 | B BRAUN | Discontinued |
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 062814 | 014 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 120MG BASE/100ML | No | No | 1987/08/28 | 1987/08/28 | B BRAUN | Discontinued |
GENTAMICIN SULFATE | 063106 | 002 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 1991/11/21 | 1991/11/21 | TEVA PARENTERAL | Discontinued |
GENTAMICIN SULFATE | 063149 | 001 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No | 1991/11/21 | 1991/11/21 | TEVA PARENTERAL | Discontinued |
GENTAMICIN SULFATE | 064054 | 001 | ANDA | GENTAMICIN SULFATE | OINTMENT;TOPICAL | EQ 0.1% BASE | No | No | 1994/04/29 | 1994/04/29 | COSETTE | Prescription |
GENTAMICIN SULFATE | 064056 | 001 | ANDA | GENTAMICIN SULFATE | CREAM;TOPICAL | EQ 0.1% BASE | No | No | 1994/04/29 | 1994/04/29 | COSETTE | Prescription |
GENTAMICIN SULFATE | 064048 | 001 | ANDA | GENTAMICIN SULFATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE | No | No | 1994/05/11 | 1994/05/11 | BAUSCH AND LOMB | Prescription |
GENTAMICIN SULFATE | 064093 | 001 | ANDA | GENTAMICIN SULFATE | OINTMENT;OPHTHALMIC | EQ 0.3% BASE | No | No | 1995/08/31 | 1995/08/31 | SCIEGEN PHARMS INC | Discontinued |
GENTAMICIN SULFATE | 065121 | 001 | ANDA | GENTAMICIN SULFATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.3% BASE | No | No | 2004/01/30 | 2004/01/30 | PADAGIS US | Prescription |
GENTAMICIN SULFATE | 065024 | 001 | ANDA | GENTAMICIN SULFATE | OINTMENT;OPHTHALMIC | EQ 0.3% BASE | No | Yes | 2004/07/30 | 2004/07/30 | FERA PHARMS LLC | Prescription |
GENTAMICIN SULFATE | 209233 | 001 | ANDA | GENTAMICIN SULFATE | OINTMENT;TOPICAL | EQ 0.1% BASE | No | No | 2018/12/31 | 2018/12/31 | ENCUBE | Discontinued |
GENTAMICIN SULFATE | 215236 | 001 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 10MG BASE/ML | No | No | 2024/01/08 | 2024/01/08 | EUGIA PHARMA | Prescription |
GENTAMICIN SULFATE | 215237 | 001 | ANDA | GENTAMICIN SULFATE | INJECTABLE;INJECTION | EQ 40MG BASE/ML | No | No | 2024/01/08 | 2024/01/08 | EUGIA PHARMA | Prescription |