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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207078
Company: ASTRAZENECA

Products on NDA 207078

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	5GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	No
LOKELMA	SODIUM ZIRCONIUM CYCLOSILICATE	10GM/PACKET	FOR SUSPENSION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207078

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207078s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207078Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207078Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207078s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207078Orig1s010ltr.pdf
09/30/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207078s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207078Orig1s008ltr.pdf
10/19/2021	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207078s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207078Orig1s007ltr.pdf
04/24/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207078s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207078Orig1s003ltr.pdf

Labels for NDA 207078

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207078s010lbl.pdf
09/30/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207078s008lbl.pdf
10/19/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207078s007lbl.pdf
04/24/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207078s003lbl.pdf
05/18/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207078s000lbl.pdf

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