Application 017766
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEPHRAMINE 5.4% | AMINO ACIDS | INJECTABLE;INJECTION | 5.4% (5.4GM/100ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-1909 | NephrAmine | HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE, and SODIUM BISULFITE | B. Braun Medical Inc. | NDA | Current |
| 0264-1909 | NephrAmine | HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE, and SODIUM BISULFITE | B. Braun Medical Inc. | NDA | Current |