Application 212070
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM CHLORIDE 14.6% | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 50MEQ/20ML (2.5MEQ/ML) | No | No |
| 002 | SODIUM CHLORIDE 14.6% | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 100MEQ/40ML (2.5MEQ/ML) | No | No |
| 003 | SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | SOLUTION;INTRAVENOUS | 400MEQ/100ML (4MEQ/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-090 | Sodium Chloride | Sodium Chloride | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-095 | Sodium Chloride | Sodium Chloride | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67421 | ORIG | 2021-05-06 |