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Generated: November 15, 2018

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Details for New Drug Application (NDA): 207078

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NDA 207078 describes LOKELMA, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the LOKELMA profile page.

The generic ingredient in LOKELMA is sodium zirconium cyclosilicate. There are one thousand four hundred and fifty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium zirconium cyclosilicate profile page.
Summary for 207078
Tradename:LOKELMA
Applicant:Astrazeneca Pharms
Ingredient:sodium zirconium cyclosilicate
Patents:7
Generic Entry Opportunity Date for 207078
Generic Entry Date for 207078*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 0310-1110 0310-1110-30 30 PACKET in 1 BOX (0310-1110-30) > 10 g in 1 PACKET (0310-1110-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength5GM/PACKET
Approval Date:May 18, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:May 18, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Mar 29, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERKALEMIA IN ADULTS
Patent:➤ Try a Free TrialPatent Expiration:Apr 19, 2032Product Flag?Substance Flag?YDelist Request?

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