FDA.reportPublic FDA data

Application 125514

Type
BLA
Sponsor
MERCK SHARP DOHME

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125514Keytrudapembrolizumab351(a)Disc2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KEYTRUDAPEMBROLIZUMABPOWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER50MGYesNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KEYTRUDAPEMBROLIZUMABMerck Sharp & Dohme LLC9333c79b-d487-4538-a9f0-71b91a02b2872026-07-10Warnings, Adverse reactionsExact identifier
application number: BLA125514
ndc (product): 0006-3026
ndc (product): 0006-3029

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme LLCBLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme LLCBLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme LLCBLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme LLCBLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme LLCBLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3026KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent
0006-3029KEYTRUDApembrolizumabMerck Sharp & Dohme Corp.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85931SUPPL 2026-05-18
85900SUPPL 2026-05-13
85653SUPPL 2026-04-08
85645SUPPL 2026-04-07
85009SUPPL 2026-02-12
85008SUPPL 2026-02-12
84292SUPPL 2025-11-25
84291SUPPL 2025-11-25
84272SUPPL 2025-11-24
82939SUPPL 2025-07-25
82916SUPPL 2025-07-24
82568SUPPL 2025-06-13
82563SUPPL 2025-06-13
82510SUPPL 2025-06-09
82484SUPPL 2025-06-09
82459SUPPL 2025-06-05
82464SUPPL 2025-06-04
82450SUPPL 2025-06-03
82310SUPPL 2025-05-27
81993SUPPL 2025-04-25
81976SUPPL 2025-04-24
81165SUPPL 2025-02-07
81010SUPPL 2025-02-05
80564SUPPL 2024-12-13
80558SUPPL 2024-12-13
80266SUPPL 2024-11-21
80263SUPPL 2024-11-21
79655SUPPL 2024-09-19
79650SUPPL 2024-09-18
79371SUPPL 2024-08-12
79348SUPPL 2024-08-09
79340SUPPL 2024-08-08
79270SUPPL 2024-08-02
78751SUPPL 2024-07-02
78811SUPPL 2024-06-18
78808SUPPL 2024-06-17
78777SUPPL 2024-06-12
77789SUPPL 2024-03-12
77778SUPPL 2024-03-12
77373SUPPL 2024-01-31
77317SUPPL 2024-01-26
77310SUPPL 2024-01-26
77218SUPPL 2024-01-16
77209SUPPL 2024-01-12
77051SUPPL 2023-12-19
77050SUPPL 2023-12-19
76865SUPPL 2023-12-15
76862SUPPL 2023-12-15
76765SUPPL 2023-12-12
76617SUPPL 2023-11-17
76583SUPPL 2023-11-16
76540SUPPL 2023-11-08
76030SUPPL 2023-11-02
76029SUPPL 2023-11-02
76021SUPPL 2023-11-01
76020SUPPL 2023-11-01
75920SUPPL 2023-10-24
75901SUPPL 2023-10-24
75832SUPPL 2023-10-17
75745SUPPL 2023-10-16
75727SUPPL 2023-10-13
75726SUPPL 2023-10-13
75087SUPPL 2023-08-16
75086SUPPL 2023-08-16
75070SUPPL 2023-08-15
75069SUPPL 2023-08-15
75021SUPPL 2023-08-09
74651SUPPL 2023-06-29
74650SUPPL 2023-06-29
73959SUPPL 2023-04-06
73945SUPPL 2023-04-04
73942SUPPL 2023-04-03
73904SUPPL 2023-03-29
73902SUPPL 2023-03-29
73302SUPPL2023-01-27
73300SUPPL2023-01-26
73299SUPPL2023-01-26
73291SUPPL2023-01-25
73286SUPPL2023-01-25
72930SUPPL2022-12-20
72920SUPPL2022-12-19
71747SUPPL2022-08-08
71743SUPPL2022-08-08
71470SUPPL2022-06-28
71447SUPPL2022-06-24
71422SUPPL2022-06-22
71134SUPPL2022-05-23
71133SUPPL2022-05-23
71127SUPPL2022-05-23
70619SUPPL2022-03-28
70579SUPPL2022-03-22
70576SUPPL2022-03-21
70117SUPPL2022-02-08
70116SUPPL2022-02-08
70108SUPPL2022-02-08
69714SUPPL2021-12-21
69625SUPPL2021-12-17
69624SUPPL2021-12-17
69497SUPPL2021-12-07
69475SUPPL2021-12-03