Details for New Drug Application (NDA): 207078
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The generic ingredient in LOKELMA is sodium zirconium cyclosilicate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.
Summary for 207078
| Tradename: | LOKELMA |
| Applicant: | Astrazeneca |
| Ingredient: | sodium zirconium cyclosilicate |
| Patents: | 14 |
Suppliers and Packaging for NDA: 207078
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078 | NDA | AstraZeneca Pharmaceuticals LP | 0310-1105 | 0310-1105-30 | 30 PACKET in 1 BOX (0310-1105-30) / 5 g in 1 PACKET (0310-1105-01) |
| LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078 | NDA | AstraZeneca Pharmaceuticals LP | 0310-1105 | 0310-1105-39 | 11 PACKET in 1 BOX (0310-1105-39) / 5 g in 1 PACKET (0310-1105-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 5GM/PACKET | ||||
| Approval Date: | May 18, 2018 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 14, 2035 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF HYPERKALEMIA IN ADULTS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 10, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERKALEMIA IN ADULTS | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Feb 10, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPERKALEMIA IN ADULTS | ||||||||
Expired US Patents for NDA 207078
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-001 | May 18, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Astrazeneca | LOKELMA | sodium zirconium cyclosilicate | FOR SUSPENSION;ORAL | 207078-002 | May 18, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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