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Application 211067
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | SOLUTION;ORAL | 20MEQ/15ML | No | No |
| 002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | SOLUTION;ORAL | 40MEQ/15ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-7061 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7061 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7062 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7062 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7062 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7062 | Potassium Chloride | Potassium Chloride | Major Pharmaceuticals | ANDA | Current |
| 48433-217 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Safecor Health, LLC | ANDA | Current |
| 48433-217 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Safecor Health, LLC | ANDA | Current |
| 48433-218 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Safecor Health, LLC | ANDA | Current |
| 48433-218 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | Safecor Health, LLC | ANDA | Current |
| 60505-6184 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6184 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6184 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6184 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6184 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6185 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6185 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6185 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6185 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
| 60505-6185 | Potassium Chloride | Potassium Chloride | Apotex Corp | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55182 | ORIG | 2018-08-16 |