Application 204790

Type: NDA
Sponsor: VIIV HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIVICAY	DOLUTEGRAVIR SODIUM	TABLET;ORAL	EQ 50MG BASE	Yes	Yes
002	TIVICAY	DOLUTEGRAVIR SODIUM	TABLET;ORAL	EQ 10MG BASE	Yes	No
003	TIVICAY	DOLUTEGRAVIR SODIUM	TABLET;ORAL	EQ 25MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-226	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-227	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
49702-228	Tivicay	dolutegravir sodium	ViiV Healthcare Company	NDA	Current
50090-1355	Tivicay	dolutegravir sodium	A-S Medication Solutions	NDA	Current
53808-1130	Tivicay	dolutegravir sodium	DOH CENTRAL PHARMACY	NDA	Current
67296-1818	Tivicay	dolutegravir sodium	RedPharm Drug, Inc.	NDA	Current
70518-1487	Tivicay	dolutegravir sodium	REMEDYREPACK INC.	NDA	Current
70518-1487	Tivicay	dolutegravir sodium	REMEDYREPACK INC.	NDA	Current
70518-1487	Tivicay	dolutegravir sodium	REMEDYREPACK INC.	NDA	Current
70518-1487	Tivicay	dolutegravir sodium	REMEDYREPACK INC.	NDA	Current
70518-1487	Tivicay	dolutegravir sodium	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83982	SUPPL	2025-10-29
83975	SUPPL	2025-10-29
78170	SUPPL	2024-04-19
78161	SUPPL	2024-04-19
72298	SUPPL	2022-10-11
72285	SUPPL	2022-10-11
68062	SUPPL	2021-07-13
68050	SUPPL	2021-07-12
66863	SUPPL	2021-03-25
66855	SUPPL	2021-03-24
63573	SUPPL	2020-06-16
63565	SUPPL	2020-06-15
62331	SUPPL	2020-03-25
62325	SUPPL	2020-03-25
60691	SUPPL	2019-10-28
60668	SUPPL	2019-10-25
55444	SUPPL	2018-09-12
55443	SUPPL	2018-09-12
55417	SUPPL	2018-09-10
55416	SUPPL	2018-09-10
50499	SUPPL	2017-11-27
50480	SUPPL	2017-11-24
47763	SUPPL	2017-03-29
47734	SUPPL	2017-03-28
32593	SUPPL	2016-06-10
19602	SUPPL	2016-06-10
40423	SUPPL	2016-04-29
32592	SUPPL	2016-04-26
10396	SUPPL	2015-08-10
19601	SUPPL	2015-08-07
19600	SUPPL	2015-01-08
32591	SUPPL	2014-12-24
40422	SUPPL	2014-05-13
32590	SUPPL	2014-05-13
43479	ORIG	2013-09-13
24481	ORIG	2013-09-13
10395	ORIG	2013-08-20
19599	ORIG	2013-08-19
54054	SUPPL	1900-01-01
52619	SUPPL	1900-01-01
52618	SUPPL	1900-01-01
52616	ORIG	1900-01-01
52615	ORIG	1900-01-01
52614	ORIG	1900-01-01

Application 204790

Related Records#

Application Products#

NDC Listings For This Application#

Documents#