Application 212248
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM CHLORIDE 23.4% | SODIUM CHLORIDE | INJECTABLE;INJECTION | 234MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0404-9978 | SODIUM CHLORIDE | sodium chloride | Henry Schein, Inc. | ANDA | Current |
| 0404-9978 | SODIUM CHLORIDE | sodium chloride | Henry Schein, Inc. | ANDA | Current |
| 52584-109 | SODIUM CHLORIDE | sodium chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-109 | SODIUM CHLORIDE | sodium chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-109 | SODIUM CHLORIDE | sodium chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 52584-109 | SODIUM CHLORIDE | sodium chloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 63323-093 | Sodium Chloride | Sodium Chloride | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 67453 | ORIG | 2021-05-11 |