| 0941-0457-01 |
0941-0457 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 2.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
6000 mL in 1 BAG (0941-0457-01) |
| 0941-0457-02 |
0941-0457 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 2.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
3000 mL in 1 BAG (0941-0457-02) |
| 0941-0457-05 |
0941-0457 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 2.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
5000 mL in 1 BAG (0941-0457-05) |
| 0941-0459-01 |
0941-0459 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
6000 mL in 1 BAG (0941-0459-01) |
| 0941-0459-02 |
0941-0459 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
3000 mL in 1 BAG (0941-0459-02) |
| 0941-0459-05 |
0941-0459 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
5000 mL in 1 BAG (0941-0459-05) |
| 0941-0484-01 |
0941-0484 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.4 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
5000 mL in 1 BAG (0941-0484-01) |
| 0941-0409-01 |
0941-0409 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
6000 mL in 1 BAG (0941-0409-01) |
| 0941-0409-05 |
0941-0409 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
3000 mL in 1 BAG (0941-0409-05) |
| 0941-0459-08 |
0941-0459 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
2000 mL in 1 BAG (0941-0459-08) |
| 0941-0415-01 |
0941-0415 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
6000 mL in 1 BAG (0941-0415-01) |
| 0941-0415-04 |
0941-0415 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
3000 mL in 1 BAG (0941-0415-04) |
| 0941-0487-01 |
0941-0487 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.4 mg/100mL; 2.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
5000 mL in 1 BAG (0941-0487-01) |
| 0941-0411-04 |
0941-0411 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
3000 mL in 1 BAG (0941-0411-04) |
| 0941-0411-05 |
0941-0411 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
1000 mL in 1 BAG (0941-0411-05) |
| 0941-0409-06 |
0941-0409 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
2000 mL in 1 BAG (0941-0409-06) |
| 0941-0409-07 |
0941-0409 |
HUMAN PRESCRIPTION DRUG |
DIANEAL Low Calcium with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
18.3 mg/100mL; 1.5 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
5000 mL in 1 BAG (0941-0409-07) |
| 0941-0415-05 |
0941-0415 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780928 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
1000 mL in 1 BAG (0941-0415-05) |
| 0941-0415-06 |
0941-0415 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
2000 mL in 1 BAG (0941-0415-06) |
| 0941-0415-07 |
0941-0415 |
HUMAN PRESCRIPTION DRUG |
DIANEAL PD-2 with Dextrose |
sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose |
INJECTION, SOLUTION |
INTRAPERITONEAL |
19780927 |
N/A |
NDA |
NDA017512 |
Vantive US Healthcare LLC |
CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE |
25.7 mg/100mL; 4.25 g/100mL; 5.08 mg/100mL; 538 mg/100mL; 448 mg/100mL |
5000 mL in 1 BAG (0941-0415-07) |