Application 022433

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Related Records

Company: ASTRAZENECA PHARMS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRILINTA	TICAGRELOR	TABLET;ORAL	90MG	Yes	Yes
002	BRILINTA	TICAGRELOR	TABLET;ORAL	60MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceutica	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceutica	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health 107, LLC	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health 107, LLC	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current

Documents

Document	Submission type	Date
85929	SUPPL	2026-05-18
85867	SUPPL	2026-05-11
80172	SUPPL	2024-11-05
80150	SUPPL	2024-11-05
80149	SUPPL	2024-11-05
77960	SUPPL	2024-03-25
77934	SUPPL	2024-03-25
71047	SUPPL	2022-05-11
71046	SUPPL	2022-05-11
71032	SUPPL	2022-05-10
68344	SUPPL	2021-08-11
68343	SUPPL	2021-08-11
68338	SUPPL	2021-08-11
66295	SUPPL	2021-02-18
66294	SUPPL	2021-02-18
66286	SUPPL	2021-02-18
65169	SUPPL	2020-11-09
65164	SUPPL	2020-11-09
65163	SUPPL	2020-11-09
64597	SUPPL	2020-09-17
64588	SUPPL	2020-09-17
64581	SUPPL	2020-09-16
63612	SUPPL	2020-06-18
63356	SUPPL	2020-06-01
63347	SUPPL	2020-05-29
63346	SUPPL	2020-05-29
60675	SUPPL	2019-10-25
60674	SUPPL	2019-10-25
60667	SUPPL	2019-10-25
58236	SUPPL	2019-04-05
58235	SUPPL	2019-04-05
58205	SUPPL	2019-04-04
52992	SUPPL	2018-03-15
52940	SUPPL	2018-03-13
45418	SUPPL	2016-09-29
45395	SUPPL	2016-09-26
45090	SUPPL	2016-08-22
44504	SUPPL	2016-07-28
7396	SUPPL	2016-07-26
38710	SUPPL	2016-07-25
42526	SUPPL	2016-02-10
38709	SUPPL	2015-09-23
7395	SUPPL	2015-09-22
38708	SUPPL	2015-09-08
7394	SUPPL	2015-09-08
17588	SUPPL	2015-03-27
7393	SUPPL	2015-03-27
17587	SUPPL	2013-12-17
7392	SUPPL	2013-12-17
7391	SUPPL	2013-10-31
29728	SUPPL	2013-04-01
17586	SUPPL	2013-04-01
17585	SUPPL	2013-01-30
7390	SUPPL	2013-01-28
42525	ORIG	2011-08-23
24307	ORIG	2011-08-23
38707	ORIG	2011-07-20
7389	ORIG	2011-07-20