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KOSELUGO

Selumetinib · Capsule

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
KOSELUGO
Generic name
Selumetinib
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
AstraZeneca Pharmaceuticals LP
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Selumetinib 10 mg/1 2289418 View
Selumetinib 25 mg/1 2289418 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Kinase Inhibitor [EPC] EPC All 89 members
Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA] MoA 3 members — no class page
Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
213756
Application type
NDA · New Drug Application
Approval date
April 10, 2020
Sponsor
ASTRAZENECA
Products on application
2
Submissions recorded
6
Products approved under application 213756.
Product Trade name Form Strength Ingredient Status TE Flags
213756-001 KOSELUGO CAPSULE SELUMETINIB SULFATE Prescription — RLD
213756-002 KOSELUGO CAPSULE SELUMETINIB SULFATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8178693 March 13, 2026 001 Yes May 6, 2020
8178693 March 13, 2026 002 Yes May 6, 2020
9562017 December 12, 2026 001 Yes U-4357 May 6, 2020
9156795 December 12, 2026 001 Yes May 6, 2020
9562017 December 12, 2026 002 Yes U-4357 May 6, 2020
9156795 December 12, 2026 002 Yes May 6, 2020
7425637 March 13, 2028 001 Yes May 6, 2020
7425637 March 13, 2028 002 Yes May 6, 2020
12364684 March 26, 2029 001 No U-4357 August 19, 2025
11813246 March 26, 2029 001 No December 7, 2023
12318367 March 26, 2029 001 No July 1, 2025
12220403 March 26, 2029 001 No February 14, 2025
12364684 March 26, 2029 002 No U-4357 August 19, 2025
11813246 March 26, 2029 002 No December 7, 2023
12220403 March 26, 2029 002 No February 14, 2025
12318367 March 26, 2029 002 No July 1, 2025
Regulatory exclusivity periods.
Code Expires Product
ODE-288 April 10, 2027 001
ODE-288 April 10, 2027 002
NPP September 10, 2028 001
NPP September 10, 2028 002
NPP November 19, 2028 001
NPP November 19, 2028 002
ODE-545 November 19, 2032 001
ODE-545 November 19, 2032 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 213756.
Type No. Action Status Date Review
Supplement 7 Labeling Approved May 26, 2026 Standard
Supplement 6 Efficacy Approved November 19, 2025 Standard
Supplement 5 Efficacy Approved September 10, 2025 Priority
Supplement 4 Efficacy Approved January 24, 2024 Standard
Supplement 3 Labeling Approved December 22, 2021 Standard
Original application 1 Type 1 - New Molecular Entity Approved April 10, 2020 Priority

Review documents

  • 0 · Supplement · June 1, 2026
  • 0 · Supplement · May 27, 2026
  • 0 · Supplement · November 21, 2025
  • 0 · Supplement · November 20, 2025
  • 0 · Supplement · September 17, 2025
  • 0 · Supplement · September 17, 2025
  • 0 · Supplement · January 25, 2024
  • 0 · Supplement · January 25, 2024
  • 0 · Supplement · December 23, 2021
  • 0 · Supplement · December 23, 2021
  • 0 · Original application · May 11, 2020
  • 0 · Original application · April 13, 2020
  • 0 · Original application · April 10, 2020

Adverse event reports

Source: openFDA FAERS
1,530
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SELUMETINIB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0310-0610-28 0310-0610 AstraZeneca Pharmaceuticals LP 28 CAPSULE in 1 BOTTLE (0310-0610-28) June 11, 2021
0310-0610-60 0310-0610 AstraZeneca Pharmaceuticals LP 60 CAPSULE in 1 BOTTLE (0310-0610-60) April 16, 2020
0310-0625-28 0310-0625 AstraZeneca Pharmaceuticals LP 28 CAPSULE in 1 BOTTLE (0310-0625-28) June 11, 2021
0310-0625-60 0310-0625 AstraZeneca Pharmaceuticals LP 60 CAPSULE in 1 BOTTLE (0310-0625-60) April 16, 2020
0310-0610 0310-0610 AstraZeneca Pharmaceuticals LP — April 16, 2020
0310-0625 0310-0625 AstraZeneca Pharmaceuticals LP — April 16, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.