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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213756
Company: ASTRAZENECA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KOSELUGO SELUMETINIB SULFATE EQ 10MG BASE CAPSULE;ORAL Prescription None Yes No
KOSELUGO SELUMETINIB SULFATE EQ 25MG BASE CAPSULE;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
04/10/2020 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213756s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213756Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213756Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2024 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213756s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213756Origs004ltr.pdf
12/22/2021 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213756Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213756Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/24/2024 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213756s004lbl.pdf
12/22/2021 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213756Orig1s003lbl.pdf
04/10/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213756s000lbl.pdf
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