AMINOSYN II IN DEXTROSE INJECTION DIN 00839302
Health Canada record
| Active ingredient(s) | L-ISOLEUCINE 280 MG; L-LEUCINE 425 MG; L-LYSINE (L-LYSINE ACETATE) 446 MG; METHIONINE 73 MG; L-PHENYLALANINE 126 MG; L-THREONINE 170 MG; TRYPTOPHAN 85 MG; L-VALINE 212 MG; L-ALANINE 422 MG; L-ARGININE 432 MG; L-ASPARTIC ACID 298 MG; GLUTAMIC ACID 314 MG; GLYCINE 212 MG; HISTIDINE 128 MG; L-PROLINE 307 MG; SERINE 225 MG; N-ACETYL-L-TYROSINE 115 MG; DEXTROSE 10 G |
|---|---|
| Dosage form | Solution |
| Route | Intravenous |
| Schedule | ETHICAL |
| Class | Human |
| ATC | B05BA10 COMBINATIONS |
| Original market date | 31-Dec-1991 |
| Current status date | 03-Aug-2012 |
| Source | Health Canada DPD |
Establishment licence of the holder
Hospira Healthcare India Pvt. Ltd. — licence , not currently licensed, last inspection rating NC (2017-07-10).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing L-ISOLEUCINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 00404160 | AMINOSYN 5% | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 360 MG; L-LEUCINE 470 MG; L-LYSINE (L-LYSINE ACETATE) 360 MG; METHIONINE 200 MG; L-PHENYLALANINE 220 MG; L-THREONINE 260 MG; TRYPTOPHAN 80 MG; L-VALINE 400 MG; L-TYROSINE 44 MG; L-ALANINE 640 MG; L-ARGININE 490 MG; GLYCINE 640 MG; L-PROLINE 430 MG; SERINE 210 MG; HISTIDINE 150 MG | Cancelled Post Market |
| 00613320 | AMINOSYN 8.5% | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 620 MG; METHIONINE 340 MG; TRYPTOPHAN 150 MG; L-ARGININE 850 MG; SERINE 370 MG; L-LEUCINE 810 MG; L-PHENYLALANINE 380 MG; L-VALINE 680 MG; HISTIDINE 260 MG; L-TYROSINE 44 MG; L-LYSINE (L-LYSINE ACETATE) 624 MG; L-THREONINE 460 MG; L-ALANINE 1.1 G; L-PROLINE 750 MG; GLYCINE 1.1 G | Cancelled Post Market |
| 00742619 | AMINOSYN II | ICU MEDICAL CANADA INC | Solution | L-ISOLEUCINE 660 MG; L-LEUCINE 1000 MG; L-LYSINE (L-LYSINE ACETATE) 1050 MG; METHIONINE 172 MG; L-PHENYLALANINE 298 MG; L-THREONINE 400 MG; TRYPTOPHAN 200 MG; L-VALINE 500 MG; L-ALANINE 993 MG; L-ARGININE 1018 MG; L-ASPARTIC ACID 700 MG; GLUTAMIC ACID 738 MG; GLYCINE 500 MG; HISTIDINE 300 MG; L-PROLINE 722 MG; SERINE 530 MG; N-ACETYL-L-TYROSINE 270 MG | Dormant |
| 00742635 | AMINOSYN II 7% INJECTION | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 462 MG; L-LEUCINE 700 MG; L-LYSINE (L-LYSINE ACETATE) 735 MG; METHIONINE 120 MG; L-PHENYLALANINE 209 MG; L-THREONINE 280 MG; TRYPTOPHAN 140 MG; L-VALINE 350 MG; L-ALANINE 695 MG; L-ARGININE 713 MG; L-ASPARTIC ACID 490 MG; GLUTAMIC ACID 517 MG; GLYCINE 350 MG; HISTIDINE 210 MG; L-PROLINE 505 MG; SERINE 371 MG; N-ACETYL-L-TYROSINE 189 MG | Cancelled Post Market |
| 00742724 | AMINOSYN II 7% M IN 10% DEXTROSE(DUAL CHAMBER) | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 231 MG; L-LEUCINE 350 MG; L-LYSINE (L-LYSINE ACETATE) 368 MG; METHIONINE 60 MG; L-PHENYLALANINE 104 MG; L-THREONINE 140 MG; TRYPTOPHAN 70 MG; L-VALINE 175 MG; L-ALANINE 348 MG; L-ARGININE 356 MG; L-ASPARTIC ACID 245 MG; GLUTAMIC ACID 258 MG; GLYCINE 175 MG; HISTIDINE 105 MG; L-PROLINE 252 MG; SERINE 186 MG; N-ACETYL-L-TYROSINE 94 MG; DEXTROSE 5 G; SODIUM CHLORIDE 120 MG; POTASSIUM CHLORIDE 97 MG; MAGNESIUM CHLORIDE 30 MG; SODIUM PHOSPHATE DIBASIC 49 MG | Cancelled Post Market |
| 00742740 | AMINOSYN II 7% WITH 10% DEXTROSE | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 231 MG; L-LEUCINE 350 MG; L-LYSINE (L-LYSINE ACETATE) 368 MG; METHIONINE 60 MG; L-PHENYLALANINE 104 MG; L-THREONINE 140 MG; TRYPTOPHAN 70 MG; L-VALINE 175 MG; L-ALANINE 348 MG; L-ARGININE 356 MG; L-ASPARTIC ACID 245 MG; GLUTAMIC ACID 258 MG; GLYCINE 175 MG; HISTIDINE 105 MG; L-PROLINE 252 MG; SERINE 185 MG; N-ACETYL-L-TYROSINE 94 MG; DEXTROSE 5 G | Cancelled Post Market |
| 00742759 | AMINOSYN II 7% WITH 50% DEXTROSE | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 231 MG; L-LEUCINE 350 MG; L-LYSINE (L-LYSINE ACETATE) 368 MG; METHIONINE 60 MG; L-PHENYLALANINE 104 MG; L-THREONINE 140 MG; TRYPTOPHAN 70 MG; L-VALINE 175 MG; L-ALANINE 348 MG; L-ARGININE 356 MG; L-ASPARTIC ACID 245 MG; GLUTAMIC ACID 258 MG; GLYCINE 175 MG; HISTIDINE 105 MG; L-PROLINE 252 MG; SERINE 185 MG; N-ACETYL-L-TYROSINE 94 MG; DEXTROSE 25 G | Cancelled Post Market |
| 00742627 | AMINOSYN II 8.5% INJECTION | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 561 MG; L-LEUCINE 850 MG; L-LYSINE (L-LYSINE ACETATE) 893 MG; METHIONINE 146 MG; L-PHENYLALANINE 253 MG; L-THREONINE 340 MG; TRYPTOPHAN 170 MG; L-VALINE 425 MG; L-ALANINE 844 MG; L-ARGININE 865 MG; L-ASPARTIC ACID 595 MG; GLUTAMIC ACID 627 MG; GLYCINE 425 MG; HISTIDINE 255 MG; L-PROLINE 614 MG; SERINE 450 MG; N-ACETYL-L-TYROSINE 230 MG | Cancelled Post Market |
| 00742716 | AMINOSYN II 8.5% M IN 20% DEXTROSE (DUAL CHAMBER) | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 280 MG; L-LEUCINE 425 MG; L-LYSINE (L-LYSINE ACETATE) 446 MG; METHIONINE 73 MG; L-PHENYLALANINE 126 MG; L-THREONINE 170 MG; TRYPTOPHAN 85 MG; L-VALINE 212 MG; L-ALANINE 422 MG; L-ARGININE 432 MG; L-ASPARTIC ACID 298 MG; GLUTAMIC ACID 314 MG; GLYCINE 212 MG; HISTIDINE 128 MG; L-PROLINE 307 MG; SERINE 225 MG; N-ACETYL-L-TYROSINE 115 MG; DEXTROSE 10 G; SODIUM CHLORIDE 120 MG; POTASSIUM CHLORIDE 97 MG; MAGNESIUM CHLORIDE 30 MG; SODIUM PHOSPHATE DIBASIC 49 MG | Cancelled Post Market |
| 00742767 | AMINOSYN II 8.5% WITH 50% DEXTROSE | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 280 MG; L-LEUCINE 425 MG; L-LYSINE (L-LYSINE ACETATE) 446 MG; METHIONINE 73 MG; L-PHENYLALANINE 126 MG; L-THREONINE 170 MG; TRYPTOPHAN 85 MG; L-VALINE 212 MG; L-ALANINE 422 MG; L-ARGININE 432 MG; L-ASPARTIC ACID 298 MG; GLUTAMIC ACID 314 MG; GLYCINE 212 MG; HISTIDINE 128 MG; L-PROLINE 307 MG; SERINE 225 MG; N-ACETYL-L-TYROSINE 115 MG; DEXTROSE 25 G | Cancelled Post Market |
| 00839310 | AMINOSYN II IN DEXTROSE INJECTION | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 280 MG; L-LEUCINE 425 MG; L-LYSINE (L-LYSINE ACETATE) 446 MG; METHIONINE 73 MG; L-PHENYLALANINE 126 MG; L-THREONINE 170 MG; TRYPTOPHAN 85 MG; L-VALINE 212 MG; L-ALANINE 422 MG; L-ARGININE 432 MG; L-ASPARTIC ACID 298 MG; GLUTAMIC ACID 314 MG; GLYCINE 212 MG; HISTIDINE 128 MG; L-PROLINE 307 MG; SERINE 225 MG; N-ACETYL-L-TYROSINE 115 MG; DEXTROSE 20 G | Cancelled Post Market |
| 00742783 | AMINOSYN II IN DEXTROSE INJECTION | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 330 MG; L-LEUCINE 500 MG; L-LYSINE (L-LYSINE ACETATE) 525 MG; METHIONINE 85 MG; L-PHENYLALANINE 149 MG; L-THREONINE 200 MG; TRYPTOPHAN 100 MG; L-VALINE 230 MG; L-ALANINE 496 MG; L-ARGININE 509 MG; L-ASPARTIC ACID 330 MG; GLUTAMIC ACID 369 MG; GLYCINE 250 MG; HISTIDINE 150 MG; L-PROLINE 361 MG; SERINE 265 MG; N-ACETYL-L-TYROSINE 135 MG; DEXTROSE 25 G | Cancelled Post Market |
| 00851531 | AMINOSYN II WITH ELECTROLYTES IN DEXTROSE INJECTION WITH CALCIUM | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 280 MG; L-LEUCINE 425 MG; L-LYSINE (LYSINE ACETATE) 446 MG; METHIONINE 73 MG; L-PHENYLALANINE 126 MG; L-THREONINE 170 MG; TRYPTOPHAN 85 MG; L-VALINE 212 MG; L-ALANINE 422 MG; L-ARGININE 432 MG; L-ASPARTIC ACID 298 MG; GLUTAMIC ACID 314 MG; GLYCINE 212 MG; HISTIDINE 128 MG; L-PROLINE 307 MG; SERINE 225 MG; ACETYL-L-TYROSINE 115 MG; DEXTROSE 25 G; SODIUM CHLORIDE 205 MG; POTASSIUM CHLORIDE 22 MG; MAGNESIUM CHLORIDE 51 MG; CALCIUM CHLORIDE 37 MG; POTASSIUM PHOSPHATE DIBASIC 261 MG | Cancelled Post Market |
| 00851574 | AMINOSYN II WITH ELECTROLYTES IN DEXTROSE INJECTION WITH CALCIUM | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 280 MG; L-LEUCINE 425 MG; LYSINE (LYSINE ACETATE) 446 MG; METHIONINE 73 MG; L-PHENYLALANINE 126 MG; L-THREONINE 170 MG; TRYPTOPHAN 85 MG; L-VALINE 212 MG; L-ALANINE 422 MG; L-ARGININE 432 MG; L-ASPARTIC ACID 298 MG; GLUTAMIC ACID 314 MG; GLYCINE 212 MG; HISTIDINE 128 MG; L-PROLINE 307 MG; SERINE 225 MG; ACETYL-L-TYROSINE 115 MG; DEXTROSE 20 G; SODIUM CHLORIDE 205 MG; POTASSIUM CHLORIDE 22 MG; MAGNESIUM CHLORIDE 51 MG; CALCIUM CHLORIDE 37 MG; POTASSIUM PHOSPHATE DIBASIC 261 MG | Cancelled Post Market |
| 00851566 | AMINOSYN II WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 231 MG; L-LEUCINE 350 MG; L-LYSINE (L-LYSINE ACETATE) 368 MG; METHIONINE 60 MG; L-PHENYLALANINE 104 MG; L-THREONINE 140 MG; TRYPTOPHAN 70 MG; L-VALINE 175 MG; L-ALANINE 348 MG; L-ARGININE 356 MG; L-ASPARTIC ACID 245 MG; GLUTAMIC ACID 258 MG; GLYCINE 175 MG; HISTIDINE 105 MG; L-PROLINE 252 MG; SERINE 185 MG; ACETYL-L-TYROSINE 94 MG; DEXTROSE 25 G; SODIUM CHLORIDE 205 MG; POTASSIUM CHLORIDE 22 MG; MAGNESIUM CHLORIDE 51 MG; CALCIUM CHLORIDE 37 MG; POTASSIUM PHOSPHATE DIBASIC 261 MG | Cancelled Post Market |
| 00731366 | AMINOSYN-PF 10% | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 760 MG; L-LEUCINE 1.2 G; L-LYSINE (L-LYSINE ACETATE) 677 MG; METHIONINE 180 MG; L-PHENYLALANINE 427 MG; L-THREONINE 512 MG; TRYPTOPHAN 180 MG; L-VALINE 673 MG; L-ALANINE 698 MG; L-ARGININE 1.227 G; L-ASPARTIC ACID 527 MG; GLUTAMIC ACID 820 MG; HISTIDINE 312 MG; L-PROLINE 812 MG; SERINE 495 MG; TAURINE 70 MG; L-TYROSINE 44 MG; GLYCINE 385 MG | Cancelled Post Market |
| 00731358 | AMINOSYN-PF 7% | HOSPIRA HEALTHCARE ULC | Solution | L-ISOLEUCINE 534 MG; L-LEUCINE 831 MG; L-LYSINE (L-LYSINE ACETATE) 475 MG; METHIONINE 125 MG; L-PHENYLALANINE 300 MG; L-THREONINE 360 MG; TRYPTOPHAN 125 MG; L-VALINE 452 MG; L-ALANINE 490 MG; L-ARGININE 861 MG; L-ASPARTIC ACID 370 MG; GLUTAMIC ACID 576 MG; HISTIDINE 220 MG; L-PROLINE 570 MG; SERINE 347 MG; TAURINE 50 MG; L-TYROSINE 44 MG; GLYCINE 270 MG | Cancelled Post Market |
| 02065665 | VAMIN N | FRESENIUS KABI AB | Solution | L-ISOLEUCINE 390 MG; L-LEUCINE 530 MG; L-LYSINE (L-LYSINE HYDROCHLORIDE) 390 MG; METHIONINE 190 MG; L-PHENYLALANINE 550 MG; L-THREONINE 300 MG; TRYPTOPHAN 100 MG; L-VALINE 425 MG; L-ALANINE 300 MG; L-ARGININE 330 MG; L-ASPARTIC ACID 410 MG; L-CYSTEINE (L-CYSTEINE HYDROCHLORIDE) 140 MG; GLUTAMIC ACID 900 MG; GLYCINE 210 MG; HISTIDINE 240 MG; L-PROLINE 810 MG; SERINE 750 MG; L-TYROSINE 50 MG; CALCIUM CHLORIDE 36.8 MG; MAGNESIUM SULFATE 37 MG; POTASSIUM CHLORIDE 37.5 MG; POTASSIUM HYDROXIDE 97 MG; SODIUM HYDROXIDE 200 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 4280 | 2004-06-04 | New Drug Submission (NDS) | MANUFACTURER NAME CHANGE |
International API supply for L-ISOLEUCINE
4 active FDA Drug Master Files.
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