Application 208019
- Type
- NDA
- Sponsor
- PHARMA RES SOFTWARE
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | FOR SOLUTION;ORAL | 20MEQ | Yes | Yes |
| 002 | POKONZA | POTASSIUM CHLORIDE | FOR SOLUTION;ORAL | 10MEQ | Yes | No |
| 003 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | FOR SOLUTION;ORAL | 40MEQ | Yes | Yes |
| 004 | POKONZA | POTASSIUM CHLORIDE | FOR SOLUTION;ORAL | 15MEQ | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0603-1554 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1554 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1554 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 64950-321 | Potassium Chloride | Potassium Chloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-321 | Potassium Chloride | Potassium Chloride | Genus Lifesciences Inc. | NDA | Current |
| 69543-379 | Potassium Chloride for Oral Solution | Potassium Chloride | Virtus Pharmaceuticals | NDA | Current |
| 69543-379 | Potassium Chloride for Oral Solution | Potassium Chloride | Virtus Pharmaceuticals | NDA | Current |
| 69543-379 | Potassium Chloride for Oral Solution | Potassium Chloride | Virtus Pharmaceuticals | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62070 | SUPPL | 2020-03-06 |
| 62055 | SUPPL | 2020-03-06 |
| 59317 | SUPPL | 2020-01-03 |
| 59308 | SUPPL | 2019-07-11 |
| 44970 | ORIG | 2016-05-04 |
| 23047 | ORIG | 2016-05-04 |
| 10640 | ORIG | 2015-08-21 |
| 40611 | ORIG | 2015-08-20 |