Application 208065

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAGRISSO	OSIMERTINIB MESYLATE	TABLET;ORAL	EQ 40MG BASE	Yes	No
002	TAGRISSO	OSIMERTINIB MESYLATE	TABLET;ORAL	EQ 80MG BASE	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79737	SUPPL	2024-09-26
79736	SUPPL	2024-09-26
78315	SUPPL	2024-04-30
78306	SUPPL	2024-04-30
77577	SUPPL	2024-02-20
77558	SUPPL	2024-02-16
77389	SUPPL	2024-02-02
77380	SUPPL	2024-02-01
74612	SUPPL	2023-06-22
74584	SUPPL	2023-06-22
72471	SUPPL	2022-10-26
72449	SUPPL	2022-10-24
72225	SUPPL	2022-10-03
72209	SUPPL	2022-10-03
69937	SUPPL	2022-01-20
69928	SUPPL	2022-01-20
68207	SUPPL	2021-07-27
68195	SUPPL	2021-07-27
65680	SUPPL	2020-12-22
65624	SUPPL	2020-12-18
65595	SUPPL	2020-12-15
65582	SUPPL	2020-12-14
65559	SUPPL	2020-12-10
65555	SUPPL	2020-12-10
63400	SUPPL	2020-06-02
63397	SUPPL	2020-06-02
61425	SUPPL	2019-12-23
61407	SUPPL	2019-12-23
55371	SUPPL	2018-08-30
55351	SUPPL	2018-08-29
53773	SUPPL	2018-04-23
53772	SUPPL	2018-04-23
53732	SUPPL	2018-04-19
50307	SUPPL	2017-11-06
50246	SUPPL	2017-10-31
47821	SUPPL	2017-04-03
47794	SUPPL	2017-03-30
47283	SUPPL	2017-02-22
45499	SUPPL	2016-09-30
45077	SUPPL	2016-08-17
45128	SUPPL	2016-08-12
23049	ORIG	2015-12-23
44971	ORIG	2015-12-11
19981	ORIG	2015-11-13
10641	ORIG	2015-11-13

Application 208065

Related Records#

Application Products#

NDC Listings For This Application#

Documents#