Application 019531
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NUTRILIPID 10% | SOYBEAN OIL | INJECTABLE;INJECTION | 10% | Yes | Yes |
| 002 | NUTRILIPID 20% | SOYBEAN OIL | INJECTABLE;INJECTION | 20% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-4460 | NutriLipid I.V. Fat Emulsion | Soybean Oil | B. Braun Medical Inc. | NDA | Current |
| 0264-4460 | NutriLipid I.V. Fat Emulsion | Soybean Oil | B. Braun Medical Inc. | NDA | Current |
| 0264-4460 | NutriLipid I.V. Fat Emulsion | Soybean Oil | B. Braun Medical Inc. | NDA | Current |
| 0264-4460 | NutriLipid I.V. Fat Emulsion | Soybean Oil | B. Braun Medical Inc. | NDA | Current |