Application 211087
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 14.9MG/ML | No | No |
| 002 | POTASSIUM CHLORIDE 10MEQ | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 746MG/100ML | No | No |
| 003 | POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 29.8MG/ML | No | No |
| 004 | POTASSIUM CHLORIDE 40MEQ | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 2.98GM/100ML | No | No |
| 005 | POTASSIUM CHLORIDE 20MEQ | POTASSIUM CHLORIDE | INJECTABLE;INJECTION | 1.49GM/100ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 65219-004 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-004 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-006 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-006 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-008 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-008 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-010 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-010 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-012 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 65219-012 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 65096 | ORIG | 2020-10-30 |