Application 125514

Type: BLA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEYTRUDA	PEMBROLIZUMAB	POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER	50MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme LLC	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme LLC	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme LLC	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme LLC	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme LLC	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3026	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current
0006-3029	KEYTRUDA	pembrolizumab	Merck Sharp & Dohme Corp.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85931	SUPPL	2026-05-18
85900	SUPPL	2026-05-13
85653	SUPPL	2026-04-08
85645	SUPPL	2026-04-07
85009	SUPPL	2026-02-12
85008	SUPPL	2026-02-12
84292	SUPPL	2025-11-25
84291	SUPPL	2025-11-25
84272	SUPPL	2025-11-24
82939	SUPPL	2025-07-25
82916	SUPPL	2025-07-24
82568	SUPPL	2025-06-13
82563	SUPPL	2025-06-13
82510	SUPPL	2025-06-09
82484	SUPPL	2025-06-09
82459	SUPPL	2025-06-05
82464	SUPPL	2025-06-04
82450	SUPPL	2025-06-03
82310	SUPPL	2025-05-27
81993	SUPPL	2025-04-25
81976	SUPPL	2025-04-24
81165	SUPPL	2025-02-07
81010	SUPPL	2025-02-05
80564	SUPPL	2024-12-13
80558	SUPPL	2024-12-13
80266	SUPPL	2024-11-21
80263	SUPPL	2024-11-21
79655	SUPPL	2024-09-19
79650	SUPPL	2024-09-18
79371	SUPPL	2024-08-12
79348	SUPPL	2024-08-09
79340	SUPPL	2024-08-08
79270	SUPPL	2024-08-02
78751	SUPPL	2024-07-02
78811	SUPPL	2024-06-18
78808	SUPPL	2024-06-17
78777	SUPPL	2024-06-12
77789	SUPPL	2024-03-12
77778	SUPPL	2024-03-12
77373	SUPPL	2024-01-31
77317	SUPPL	2024-01-26
77310	SUPPL	2024-01-26
77218	SUPPL	2024-01-16
77209	SUPPL	2024-01-12
77051	SUPPL	2023-12-19
77050	SUPPL	2023-12-19
76865	SUPPL	2023-12-15
76862	SUPPL	2023-12-15
76765	SUPPL	2023-12-12
76617	SUPPL	2023-11-17
76583	SUPPL	2023-11-16
76540	SUPPL	2023-11-08
76030	SUPPL	2023-11-02
76029	SUPPL	2023-11-02
76021	SUPPL	2023-11-01
76020	SUPPL	2023-11-01
75920	SUPPL	2023-10-24
75901	SUPPL	2023-10-24
75832	SUPPL	2023-10-17
75745	SUPPL	2023-10-16
75727	SUPPL	2023-10-13
75726	SUPPL	2023-10-13
75087	SUPPL	2023-08-16
75086	SUPPL	2023-08-16
75070	SUPPL	2023-08-15
75069	SUPPL	2023-08-15
75021	SUPPL	2023-08-09
74651	SUPPL	2023-06-29
74650	SUPPL	2023-06-29
73959	SUPPL	2023-04-06
73945	SUPPL	2023-04-04
73942	SUPPL	2023-04-03
73904	SUPPL	2023-03-29
73902	SUPPL	2023-03-29
73302	SUPPL	2023-01-27
73300	SUPPL	2023-01-26
73299	SUPPL	2023-01-26
73291	SUPPL	2023-01-25
73286	SUPPL	2023-01-25
72930	SUPPL	2022-12-20
72920	SUPPL	2022-12-19
71747	SUPPL	2022-08-08
71743	SUPPL	2022-08-08
71470	SUPPL	2022-06-28
71447	SUPPL	2022-06-24
71422	SUPPL	2022-06-22
71134	SUPPL	2022-05-23
71133	SUPPL	2022-05-23
71127	SUPPL	2022-05-23
70619	SUPPL	2022-03-28
70579	SUPPL	2022-03-22
70576	SUPPL	2022-03-21
70117	SUPPL	2022-02-08
70116	SUPPL	2022-02-08
70108	SUPPL	2022-02-08
69714	SUPPL	2021-12-21
69625	SUPPL	2021-12-17
69624	SUPPL	2021-12-17
69497	SUPPL	2021-12-07
69475	SUPPL	2021-12-03

Application 125514

Related Records#

Application Products#

NDC Listings For This Application#

Documents#