Application 019374
- Type
- NDA
- Sponsor
- ICU MEDICAL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMINOSYN-HBC 7% | AMINO ACIDS | INJECTABLE;INJECTION | 7% (7GM/100ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4168 | Aminosyn | Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alani | Hospira, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 17364 | SUPPL | 2004-05-27 |