Application 207078
- Type
- NDA
- Sponsor
- ASTRAZENECA PHARMS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOKELMA | SODIUM ZIRCONIUM CYCLOSILICATE | FOR SUSPENSION;ORAL | 5GM/PACKET | Yes | No |
| 002 | LOKELMA | SODIUM ZIRCONIUM CYCLOSILICATE | FOR SUSPENSION;ORAL | 10GM/PACKET | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1105 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-1110 | LOKELMA | sodium zirconium cyclosilicate | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77461 | SUPPL | 2024-02-12 |
| 77443 | SUPPL | 2024-02-09 |
| 72228 | SUPPL | 2022-10-03 |
| 72208 | SUPPL | 2022-10-03 |
| 69042 | SUPPL | 2021-10-21 |
| 69032 | SUPPL | 2021-10-20 |
| 62699 | SUPPL | 2020-04-28 |
| 62681 | SUPPL | 2020-04-27 |
| 54477 | ORIG | 2018-06-08 |
| 54271 | ORIG | 2018-05-21 |
| 54257 | ORIG | 2018-05-18 |