Application 208772

Type: NDA
Sponsor: ARIAD

Related Records

Company: ARIAD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALUNBRIG	BRIGATINIB	TABLET;ORAL	30MG	Yes	No
002	ALUNBRIG	BRIGATINIB	TABLET;ORAL	90MG	Yes	No
003	ALUNBRIG	BRIGATINIB	TABLET;ORAL	180MG	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-090	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-113	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-180	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Millennium Pharmaceuticals, Inc.	NDA	Current
63020-198	Alunbrig	brigatinib	Takeda Pharmaceuticals America, Inc.	NDA	Current
76189-113	Alunbrig	Brigatinib	ARIAD Pharmaceuticals Inc.	NDA	Current

Documents

Document	Submission type	Date
70387	SUPPL	2022-03-03
70313	SUPPL	2022-03-01
68808	SUPPL	2021-09-29
68793	SUPPL	2021-09-28
63321	SUPPL	2020-05-28
63288	SUPPL	2020-05-22
57089	SUPPL	2018-12-31
57008	SUPPL	2018-12-26
48573	ORIG	2017-05-30
48165	ORIG	2017-04-28
48164	ORIG	2017-04-28