FDA.reportPublic FDA data

Application 212018

Type
NDA
Sponsor
JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BALVERSAERDAFITINIBTABLET;ORAL3MGYesNo
002BALVERSAERDAFITINIBTABLET;ORAL4MGYesNo
003BALVERSAERDAFITINIBTABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59676-030BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-030BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-030BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-030BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-030BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-040BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-040BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-040BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-040BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-040BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-050BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-050BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-050BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-050BALVERSAErdafitinibJanssen Products LPNDACurrent
59676-050BALVERSAErdafitinibJanssen Products LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83853SUPPL 2025-10-21
83820SUPPL 2025-10-20
79855SUPPL 2024-10-10
79852SUPPL 2024-10-10
77280SUPPL 2024-01-23
77279SUPPL 2024-01-23
77277SUPPL 2024-01-23
77260SUPPL 2024-01-22
77259SUPPL 2024-01-22
77258SUPPL 2024-01-22
73813SUPPL 2023-03-22
73809SUPPL 2023-03-21
73146SUPPL2023-01-12
73145SUPPL2023-01-12
70862SUPPL2022-04-29
70861SUPPL2022-04-29
70847SUPPL2022-04-28
70846SUPPL2022-04-28
62541SUPPL2020-04-10
62426SUPPL2020-04-03
58635ORIG2019-05-09
58337ORIG2019-04-15
58312ORIG2019-04-12