Application 206814
- Type
- NDA
- Sponsor
- GENUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | SOLUTION;ORAL | 20MEQ/15ML | Yes | No |
| 002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | SOLUTION;ORAL | 40MEQ/15ML | Yes | Yes |
| 003 | POKONZA | POTASSIUM CHLORIDE | SOLUTION;ORAL | 10MEQ/15ML | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0603-1542 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1542 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1542 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1543 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1543 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 0603-1543 | Potassium Chloride | Potassium Chloride | Par Pharmaceutical | NDA | Current |
| 17856-1542 | Potassium Chloride | Potassium Chloride | Atlantic Biologicals Corps | NDA | Current |
| 17856-1542 | Potassium Chloride | Potassium Chloride | Atlantic Biologicals Corps | NDA | Current |
| 17856-1543 | Potassium Chloride | Potassium Chloride | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 17856-1543 | Potassium Chloride | Potassium Chloride | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 17856-1544 | Potassium Chloride | Potassium Chloride | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 17856-1544 | Potassium Chloride | Potassium Chloride | ATLANTIC BIOLOGICALS CORP. | NDA | Current |
| 64950-320 | Potassium Chloride | Potassium Chloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-320 | Potassium Chloride | Potassium Chloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-320 | Potassium Chloride | Potassium Chloride | Genus Lifesciences Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-047 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
| 66689-048 | Potassium Chloride | Potassium Chloride | VistaPharm, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62078 | SUPPL | 2020-03-09 |
| 62054 | SUPPL | 2020-03-06 |
| 58836 | SUPPL | 2019-05-23 |
| 58833 | SUPPL | 2019-05-22 |
| 57614 | SUPPL | 2019-02-15 |
| 57587 | SUPPL | 2019-02-13 |
| 44949 | ORIG | 2015-03-10 |
| 43528 | ORIG | 2015-03-10 |
| 32829 | ORIG | 2014-12-30 |
| 19736 | ORIG | 2014-12-23 |