FDA.reportPublic FDA data

Application 213756

Type
NDA
Sponsor
ASTRAZENECA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KOSELUGOSELUMETINIB SULFATECAPSULE; ORAL25MGYesNo
002KOSELUGOSELUMETINIB SULFATECAPSULE; ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-0610KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0610KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0610KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0610KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0625KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0625KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0625KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent
0310-0625KOSELUGOSELUMETINIBAstraZeneca Pharmaceuticals LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84242SUPPL 2025-11-21
84234SUPPL 2025-11-20
83366SUPPL 2025-09-17
83365SUPPL 2025-09-17
77298SUPPL 2024-01-25
77292SUPPL 2024-01-25
69750SUPPL2021-12-23
69749SUPPL2021-12-23
62883ORIG2020-05-11
62549ORIG2020-04-13
62540ORIG2020-04-10