Application 208573

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENCLEXTA	VENETOCLAX	TABLET;ORAL	10MG	Yes	No
002	VENCLEXTA	VENETOCLAX	TABLET;ORAL	50MG	Yes	No
003	VENCLEXTA	VENETOCLAX	TABLET;ORAL	100MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0561	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0566	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0576	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current
0074-0579	Venclexta	Venetoclax	AbbVie Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
86012	SUPPL	2026-05-22
86002	SUPPL	2026-05-21
85129	SUPPL	2026-02-24
85099	SUPPL	2026-02-23
71341	SUPPL	2022-06-16
71337	SUPPL	2022-06-16
69109	SUPPL	2021-10-25
69108	SUPPL	2021-10-25
69087	SUPPL	2021-10-25
68892	SUPPL	2021-10-06
68876	SUPPL	2021-10-05
65545	SUPPL	2020-12-09
65544	SUPPL	2020-12-09
65487	SUPPL	2020-12-02
65302	SUPPL	2020-11-23
65296	SUPPL	2020-11-20
64941	SUPPL	2020-10-20
64940	SUPPL	2020-10-20
64932	SUPPL	2020-10-16
64931	SUPPL	2020-10-16
64929	SUPPL	2020-10-16
63710	SUPPL	2020-06-26
63563	SUPPL	2020-06-15
63396	SUPPL	2020-06-02
63395	SUPPL	2020-06-02
63385	SUPPL	2020-06-02
60159	SUPPL	2019-09-30
59490	SUPPL	2019-07-29
59489	SUPPL	2019-07-29
59488	SUPPL	2019-07-29
59487	SUPPL	2019-07-29
59486	SUPPL	2019-07-29
59485	SUPPL	2019-07-29
59467	SUPPL	2019-07-26
59466	SUPPL	2019-07-26
59465	SUPPL	2019-07-26
58750	SUPPL	2019-05-16
58734	SUPPL	2019-05-15
56719	SUPPL	2018-12-12
56530	SUPPL	2018-11-21
55447	SUPPL	2018-09-12
55446	SUPPL	2018-09-12
55428	SUPPL	2018-09-11
55427	SUPPL	2018-09-11
54591	SUPPL	2018-06-14
54590	SUPPL	2018-06-14
54480	SUPPL	2018-06-08
54479	SUPPL	2018-06-08
50852	SUPPL	2017-12-26
43550	ORIG	2016-05-19
24536	ORIG	2016-05-19
32912	ORIG	2016-04-11
19998	ORIG	2016-04-11

Application 208573

Related Records#

Application Products#

NDC Listings For This Application#

Documents#