Application 209899

Type: NDA
Sponsor: CELGENE INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZEPOSIA	OZANIMOD HYDROCHLORIDE	CAPSULE;ORAL	0.23MG	Yes	No
002	ZEPOSIA	OZANIMOD HYDROCHLORIDE	CAPSULE;ORAL	0.46MG	Yes	No
003	ZEPOSIA	OZANIMOD HYDROCHLORIDE	CAPSULE;ORAL	0.92MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-810	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-820	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current
59572-890	ZEPOSIA	ozanimod hydrochloride	Celgene Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79540	SUPPL	2024-09-03
79539	SUPPL	2024-09-03
79524	SUPPL	2024-09-03
79523	SUPPL	2024-09-03
78738	SUPPL	2024-07-02
78737	SUPPL	2024-07-02
78745	SUPPL	2024-06-07
78697	SUPPL	2024-06-06
78696	SUPPL	2024-06-06
75632	SUPPL	2023-10-02
75059	SUPPL	2023-08-14
75058	SUPPL	2023-08-14
75057	SUPPL	2023-08-14
72223	SUPPL	2022-10-03
72222	SUPPL	2022-10-03
72191	SUPPL	2022-09-30
69705	SUPPL	2021-12-21
69619	SUPPL	2021-12-17
69618	SUPPL	2021-12-17
67633	SUPPL	2021-06-01
67624	SUPPL	2021-05-28
62646	ORIG	2020-04-23
62345	ORIG	2020-03-26
62339	ORIG	2020-03-26

Application 209899

Related Records#

Application Products#

NDC Listings For This Application#

Documents#