Application 218475
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) | Yes | Yes |
| 002 | EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE | EPINEPHRINE BITARTRATE | SOLUTION;INTRAVENOUS | EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83642 | SUPPL | 2025-10-03 |
| 81429 | ORIG | 2025-03-04 |
| 81393 | ORIG | 2025-03-03 |