Application 210921
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MEQ | No | No |
| 002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MEQ | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7216 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 50090-5335 | Potassium Chloride | Potassium Chloride | A-S Medication Solutions | ANDA | Current |
| 50090-5335 | Potassium Chloride | Potassium Chloride | A-S Medication Solutions | ANDA | Current |
| 50090-5335 | Potassium Chloride | Potassium Chloride | A-S Medication Solutions | ANDA | Current |
| 65862-986 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-986 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-986 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-986 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-987 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-987 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-987 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-987 | Potassium Chloride | Potassium Chloride | Aurobindo Pharma Limited | ANDA | Current |
| 68001-518 | Potassium Chloride | Potassium Chloride | BluePoint Laboratories | ANDA | Current |
| 68001-518 | Potassium Chloride | Potassium Chloride | BluePoint Laboratories | ANDA | Current |
| 68788-8262 | Potassium Chloride | Potassium Chloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2964 | Potassium Chloride | Potassium Chloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2964 | Potassium Chloride | Potassium Chloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2964 | Potassium Chloride | Potassium Chloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2964 | Potassium Chloride | Potassium Chloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-536 | Potassium Chloride | Potassium Chloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |