0338-1101-04 |
0338-1101 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
19970929 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 20 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
2000 mL in 1 BAG (0338-1101-04) |
0338-1138-03 |
0338-1138 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
19970929 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 20 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
1000 mL in 1 BAG (0338-1138-03) |
0338-7007-04 |
0338-7007 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 10 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
4 BAG in 1 CARTON (0338-7007-04) / 2000 mL in 1 BAG (0338-7007-01) |
0338-7015-04 |
0338-7015 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 20 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
4 BAG in 1 CARTON (0338-7015-04) / 2000 mL in 1 BAG (0338-7015-01) |
0338-0184-04 |
0338-0184 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20200921 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1656 mg/100mL; 920 mg/100mL; 14 g/100mL; 824 mg/100mL; 384 mg/100mL; 480 mg/100mL; 584 mg/100mL; 464 mg/100mL; 320 mg/100mL; 448 mg/100mL; 544 mg/100mL; 400 mg/100mL; 336 mg/100mL; 144 mg/100mL; 32 mg/100mL; 464 mg/100mL |
4 BAG in 1 CARTON (0338-0184-04) / 2000 mL in 1 BAG (0338-0184-01) |
0338-1137-03 |
0338-1137 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
19970929 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 15 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
1000 mL in 1 BAG (0338-1137-03) |
0338-7005-06 |
0338-7005 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 10 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
6 BAG in 1 CARTON (0338-7005-06) / 1000 mL in 1 BAG (0338-7005-01) |
0338-7013-06 |
0338-7013 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 20 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
6 BAG in 1 CARTON (0338-7013-06) / 1000 mL in 1 BAG (0338-7013-01) |
0338-0180-06 |
0338-0180 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20200921 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1656 mg/100mL; 920 mg/100mL; 14 g/100mL; 824 mg/100mL; 384 mg/100mL; 480 mg/100mL; 584 mg/100mL; 464 mg/100mL; 320 mg/100mL; 448 mg/100mL; 544 mg/100mL; 400 mg/100mL; 336 mg/100mL; 144 mg/100mL; 32 mg/100mL; 464 mg/100mL |
6 BAG in 1 CARTON (0338-0180-06) / 1000 mL in 1 BAG (0338-0180-01) |
0338-0198-06 |
0338-0198 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20200921 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1242 mg/100mL; 690 mg/100mL; 5 g/100mL; 618 mg/100mL; 288 mg/100mL; 360 mg/100mL; 438 mg/100mL; 348 mg/100mL; 200 mg/100mL; 336 mg/100mL; 408 mg/100mL; 300 mg/100mL; 252 mg/100mL; 108 mg/100mL; 24 mg/100mL; 348 mg/100mL |
6 BAG in 1 CARTON (0338-0198-06) / 1000 mL in 1 BAG (0338-0198-01) |
0338-1099-04 |
0338-1099 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
19970929 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 15 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
2000 mL in 1 BAG (0338-1099-04) |
0338-1134-03 |
0338-1134 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20120320 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 10 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
1000 mL in 1 BAG (0338-1134-03) |
0338-7003-04 |
0338-7003 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 5 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
4 BAG in 1 CARTON (0338-7003-04) / 2000 mL in 1 BAG (0338-7003-01) |
0338-7011-04 |
0338-7011 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 15 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
4 BAG in 1 CARTON (0338-7011-04) / 2000 mL in 1 BAG (0338-7011-01) |
0338-0194-04 |
0338-0194 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20200921 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1656 mg/100mL; 920 mg/100mL; 10 g/100mL; 824 mg/100mL; 384 mg/100mL; 480 mg/100mL; 584 mg/100mL; 464 mg/100mL; 320 mg/100mL; 448 mg/100mL; 544 mg/100mL; 400 mg/100mL; 336 mg/100mL; 144 mg/100mL; 32 mg/100mL; 464 mg/100mL |
4 BAG in 1 CARTON (0338-0194-04) / 2000 mL in 1 BAG (0338-0194-01) |
0338-1091-04 |
0338-1091 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
19970929 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 10 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
2000 mL in 1 BAG (0338-1091-04) |
0338-1133-03 |
0338-1133 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
19970929 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 5 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
1000 mL in 1 BAG (0338-1133-03) |
0338-7001-06 |
0338-7001 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
880 mg/100mL; 489 mg/100mL; 5 g/100mL; 438 mg/100mL; 204 mg/100mL; 255 mg/100mL; 311 mg/100mL; 247 mg/100mL; 170 mg/100mL; 238 mg/100mL; 289 mg/100mL; 213 mg/100mL; 179 mg/100mL; 77 mg/100mL; 17 mg/100mL; 247 mg/100mL |
6 BAG in 1 CARTON (0338-7001-06) / 1000 mL in 1 BAG (0338-7001-01) |
0338-7009-06 |
0338-7009 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20240715 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1035 mg/100mL; 575 mg/100mL; 15 g/100mL; 515 mg/100mL; 240 mg/100mL; 300 mg/100mL; 365 mg/100mL; 290 mg/100mL; 200 mg/100mL; 280 mg/100mL; 340 mg/100mL; 250 mg/100mL; 210 mg/100mL; 90 mg/100mL; 20 mg/100mL; 290 mg/100mL |
6 BAG in 1 CARTON (0338-7009-06) / 1000 mL in 1 BAG (0338-7009-01) |
0338-0188-06 |
0338-0188 |
HUMAN PRESCRIPTION DRUG |
CLINIMIX |
Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Dextrose |
INJECTION |
INTRAVENOUS |
20200921 |
N/A |
NDA |
NDA020734 |
Baxter Healthcare Corporation |
ALANINE; ARGININE; DEXTROSE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE |
1656 mg/100mL; 920 mg/100mL; 10 g/100mL; 515 mg/100mL; 384 mg/100mL; 480 mg/100mL; 584 mg/100mL; 464 mg/100mL; 320 mg/100mL; 448 mg/100mL; 544 mg/100mL; 400 mg/100mL; 336 mg/100mL; 144 mg/100mL; 32 mg/100mL; 464 mg/100mL |
6 BAG in 1 CARTON (0338-0188-06) / 1000 mL in 1 BAG (0338-0188-01) |