Application 217512
- Type
- NDA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | SOLUTION;INTRAVENOUS | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | Yes | Yes |
| 002 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | SOLUTION;INTRAVENOUS | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | Yes | Yes |
| 003 | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | PANTOPRAZOLE SODIUM | SOLUTION;INTRAVENOUS | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 79754 | ORIG | 2024-09-27 |
| 77506 | ORIG | 2024-02-15 |
| 77502 | ORIG | 2024-02-15 |