Application 077419
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 8MEQ | No | No |
| 002 | POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MEQ | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-1318 | Potassium Chloride | Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6068 | Potassium Chloride | potassium chloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6068 | Potassium Chloride | potassium chloride | Major Pharmaceuticals | ANDA | Current |
| 42291-678 | Potassium Chloride | Potassium Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-678 | Potassium Chloride | Potassium Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-678 | Potassium Chloride | Potassium Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-679 | Potassium Chloride | Potassium Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-679 | Potassium Chloride | Potassium Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-679 | Potassium Chloride | Potassium Chloride | AvKARE, Inc. | ANDA | Current |
| 42291-679 | Potassium Chloride | Potassium Chloride | AvKARE | ANDA | Current |
| 55154-3328 | Potassium Chloride | potassium chloride | Cardinal Health | ANDA | Current |
| 55154-3328 | Potassium Chloride | potassium chloride | Cardinal Health | ANDA | Current |
| 55154-3328 | Potassium Chloride | potassium chloride | Cardinal Health | ANDA | Current |
| 55289-218 | Potassium Chloride | Potassium Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-218 | Potassium Chloride | Potassium Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-218 | Potassium Chloride | Potassium Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-218 | Potassium Chloride | Potassium Chloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 62037-559 | Potassium Chloride | Potassium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-559 | Potassium Chloride | Potassium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-559 | Potassium Chloride | Potassium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-560 | Potassium Chloride | Potassium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-560 | Potassium Chloride | Potassium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 62037-560 | Potassium Chloride | Potassium Chloride | Actavis Pharma, Inc. | ANDA | Current |
| 68071-3274 | Potassium Chloride | Potassium Chloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68151-0609 | Potassium Chloride | Potassium Chloride | Carilion Materials Management | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 18461 | ORIG | 2012-11-27 |
| 22604 | ORIG | 2012-03-28 |