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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207078
Company: ASTRAZENECA
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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