Application 203188

Type: NDA
Sponsor: VERTEX PHARMS

Related Records

Company: VERTEX PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KALYDECO	IVACAFTOR	TABLET;ORAL	150MG	Yes	Yes
002	KALYDECO	IVACAFTOR	TABLET;ORAL	75MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51167-200	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-200	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-200	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-200	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current
51167-200	Kalydeco	ivacaftor	Vertex Pharmaceuticals Incorporated	NDA	Current

Documents

Document	Submission type	Date
85472	SUPPL	2026-03-24
85409	SUPPL	2026-03-19
83566	SUPPL	2025-09-26
83538	SUPPL	2025-09-26
82415	SUPPL	2025-06-02
82312	SUPPL	2025-05-27
74992	SUPPL	2023-08-04
74985	SUPPL	2023-08-04
74172	SUPPL	2023-05-04
74170	SUPPL	2023-05-04
65742	SUPPL	2020-12-28
65705	SUPPL	2020-12-23
64686	SUPPL	2020-09-25
64674	SUPPL	2020-09-25
58486	SUPPL	2019-04-30
58482	SUPPL	2019-04-30
55263	SUPPL	2018-08-21
55209	SUPPL	2018-08-20
49206	SUPPL	2017-08-02
49201	SUPPL	2017-08-02
48445	SUPPL	2017-05-18
48442	SUPPL	2017-05-18
47159	SUPPL	2017-02-10
47155	SUPPL	2017-02-09
19444	SUPPL	2015-03-20
32389	SUPPL	2015-03-06
40271	SUPPL	2015-01-09
19443	SUPPL	2015-01-09
32388	SUPPL	2015-01-06
10180	SUPPL	2015-01-06
10179	SUPPL	2014-06-18
19442	SUPPL	2014-06-17
40270	SUPPL	2014-04-10
32387	SUPPL	2014-04-10
40269	SUPPL	2014-02-25
10178	SUPPL	2014-02-25
23957	ORIG	2012-10-12
32386	SUPPL	2012-08-29
19441	SUPPL	2012-08-29
43423	ORIG	2012-03-13
32385	ORIG	2012-01-31
19440	ORIG	2012-01-31