Application 761097

Type: BLA
Sponsor: REGENERON PHARMACEUTICALS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIBTAYO	CEMIPLIMAB-RWLC	INJECTABLE;INTRAVENOUS	350MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-008	LIBTAYO	cemiplimab-rwlc	Regeneron Pharmaceuticals, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84008	SUPPL	2025-10-31
84004	SUPPL	2025-10-31
83703	SUPPL	2025-10-09
83694	SUPPL	2025-10-09
83693	SUPPL	2025-10-09
78099	SUPPL	2024-04-09
78080	SUPPL	2024-04-08
77811	SUPPL	2024-03-13
77785	SUPPL	2024-03-12
77204	SUPPL	2024-01-11
74677	SUPPL	2023-06-30
74145	SUPPL	2023-05-02
74144	SUPPL	2023-05-02
74125	SUPPL	2023-05-01
74124	SUPPL	2023-05-01
72584	SUPPL	2022-11-09
72581	SUPPL	2022-11-08
72580	SUPPL	2022-11-08
66339	SUPPL	2021-02-23
66310	SUPPL	2021-02-22
66309	SUPPL	2021-02-22
66174	SUPPL	2021-02-10
66173	SUPPL	2021-02-10
66168	SUPPL	2021-02-09
66167	SUPPL	2021-02-09
66166	SUPPL	2021-02-09
65213	SUPPL	2020-11-13
65212	SUPPL	2020-11-13
65192	SUPPL	2020-11-12
63709	SUPPL	2020-06-26
63708	SUPPL	2020-06-26
63707	SUPPL	2020-06-26
55672	SUPPL	2019-08-21
58053	SUPPL	2019-03-21
57315	SUPPL	2019-01-22
57291	SUPPL	2019-01-22
56170	ORIG	2018-10-30
55811	ORIG	2018-10-04
55765	ORIG	2018-10-01