Application 212887

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VOCABRIA	CABOTEGRAVIR	TABLET, FILM COATED	30MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-248	Vocabria	cabotegravir sodium	ViiV Healthcare Company	NDA	Current
49702-248	Vocabria	cabotegravir sodium	ViiV Healthcare Company	NDA	Current
49702-248	Vocabria	cabotegravir sodium	ViiV Healthcare Company	NDA	Current
49702-248	Vocabria	cabotegravir sodium	ViiV Healthcare Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82008	SUPPL	2025-04-25
81943	SUPPL	2025-04-21
79748	SUPPL	2024-09-26
79747	SUPPL	2024-09-26
79716	SUPPL	2024-09-24
79715	SUPPL	2024-09-24
76838	SUPPL	2023-12-14
76810	SUPPL	2023-12-14
76807	SUPPL	2023-12-14
73624	SUPPL	2023-02-28
73617	SUPPL	2023-02-28
70659	SUPPL	2022-03-30
70658	SUPPL	2022-03-30
70651	SUPPL	2022-03-30
70650	SUPPL	2022-03-30
70599	SUPPL	2022-03-25
70594	SUPPL	2022-03-24
70142	SUPPL	2022-02-10
70129	SUPPL	2022-02-08
70059	SUPPL	2022-02-03
70043	SUPPL	2022-02-01
69735	SUPPL	2021-12-22
69732	SUPPL	2021-12-21
66473	ORIG	2021-03-03
66200	ORIG	2021-02-12
65963	ORIG	2021-01-22