Application 019438
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMINOSYN II 3.5% | AMINO ACIDS | INJECTABLE;INJECTION | 3.5% (3.5GM/100ML) | No | No |
| 002 | AMINOSYN II 5% | AMINO ACIDS | INJECTABLE;INJECTION | 5% (5GM/100ML) | No | No |
| 003 | AMINOSYN II 7% | AMINO ACIDS | INJECTABLE;INJECTION | 7% (7GM/100ML) | No | No |
| 004 | AMINOSYN II 8.5% | AMINO ACIDS | INJECTABLE;INJECTION | 8.5% (8.5GM/100ML) | No | No |
| 005 | AMINOSYN II 10% | AMINO ACIDS | INJECTABLE;INJECTION | 10% (10GM/100ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4162 | Aminosyn II | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI | Hospira, Inc. | NDA | Current |
| 0409-4164 | Aminosyn II | ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 17405 | SUPPL | 2004-05-27 |