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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 219943
Company: ASTRAZENECA

Products on NDA 219943

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KOSELUGO	SELUMETINIB SULFATE	EQ 5MG BASE	GRANULE;ORAL	Prescription	None	Yes	Yes
KOSELUGO	SELUMETINIB SULFATE	EQ 7.5MG BASE	GRANULE;ORAL	Prescription	None	Yes	No
KOSELUGO	SELUMETINIB	10MG	CAPSULE; ORAL	Prescription	None	No	No
KOSELUGO	SELUMETINIB	25MG	CAPSULE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 219943

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2025	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219943Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219943Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2026	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219943s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213756Orig1s007, 219943Orig1s003ltr.pdf
11/19/2025	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219943s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219943Orig1s002ltr.pdf

Labels for NDA 219943

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/26/2026	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219943s003lbl.pdf
11/19/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219943s002lbl.pdf
09/10/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219943Orig1s000lbl.pdf

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