Application 210395
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | No | No |
| 002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MEQ | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68382-740 | Potassium Chloride | Potassium Chloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-861 | Potassium Chloride | Potassium Chloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70771-1599 | Potassium Chloride | Potassium Chloride | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1600 | Potassium Chloride | Potassium Chloride | Zydus Lifesciences Limited | ANDA | Current |