Application 209997
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS | INJECTABLE;INJECTION | 142MG/ML;276MG/ML | No | No |
| 002 | SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SOLUTION;INTRAVENOUS | 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) | No | No |
| 003 | SODIUM PHOSPHATES | SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | SOLUTION;INTRAVENOUS | 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-881 | Sodium Phosphates | sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-884 | Sodium Phosphates | sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-886 | Sodium Phosphates | sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71755 | ORIG | 2022-08-09 |