Application 017673
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMINOSYN 5% | AMINO ACIDS | INJECTABLE;INJECTION | 5% (5GM/100ML) | No | No |
| 002 | AMINOSYN 7% | AMINO ACIDS | INJECTABLE;INJECTION | 7% (7GM/100ML) | No | No |
| 003 | AMINOSYN 10% | AMINO ACIDS | INJECTABLE;INJECTION | 10% (10GM/100ML) | No | No |
| 004 | AMINOSYN 8.5% | AMINO ACIDS | INJECTABLE;INJECTION | 8.5% (8.5GM/100ML) | No | No |
| 005 | AMINOSYN 8.5% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | INJECTABLE;INJECTION | 8.5%;102MG/100ML;522MG/100ML;410MG/100ML | No | No |
| 006 | AMINOSYN 7% (PH6) | AMINO ACIDS | INJECTABLE;INJECTION | 7% (7GM/100ML) | No | No |
| 007 | AMINOSYN 8.5% (PH6) | AMINO ACIDS | INJECTABLE;INJECTION | 8.5% (8.5GM/100ML) | No | No |
| 008 | AMINOSYN 10% (PH6) | AMINO ACIDS | INJECTABLE;INJECTION | 10% (10GM/100ML) | No | No |
| 009 | AMINOSYN 8.5% W/ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC | INJECTABLE;INJECTION | 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/100ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4187 | Aminosyn | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI | Hospira, Inc. | NDA | Current |
| 0409-4191 | Aminosyn | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI | Hospira, Inc. | NDA | Current |
| 0409-4192 | Aminosyn Sulfite Free | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI | Hospira, Inc. | NDA | Current |
| 0409-4203 | Aminosyn | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI | Hospira, Inc. | NDA | Current |