Application 211651

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.25MG BASE	Yes	No
002	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 1MG BASE	Yes	Yes
003	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.5MG BASE	Yes	No
004	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.75MG BASE	Yes	No
005	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.1MG BASE	Yes	No
006	TALZENNA	TALAZOPARIB TOSYLATE	CAPSULE;ORAL	EQ 0.35MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0296	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1195	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1501	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1501	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1751	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-1751	Talzenna	talazoparib	Pfizer Laboratories Div Pfizer Inc	NDA	Current
46014-0296	Talzenna	talazoparib	Excella GmbH & Co. KG	NDA	Current
46014-1195	Talzenna	talazoparib	Excella GmbH & Co. KG	NDA	Current
63539-295	Talzenna	talazoparib	U.S. Pharmaceuticals	NDA	Current
63539-295	Talzenna	talazoparib	U.S. Pharmaceuticals	NDA	Current
63539-295	Talzenna	talazoparib	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82570	SUPPL	2025-06-13
82561	SUPPL	2025-06-13
77417	SUPPL	2024-02-07
77415	SUPPL	2024-02-07
74581	SUPPL	2023-06-21
74554	SUPPL	2023-06-20
68697	SUPPL	2021-09-21
68696	SUPPL	2021-09-21
68670	SUPPL	2021-09-21
68572	SUPPL	2021-09-10
68569	SUPPL	2021-09-10
67835	SUPPL	2021-06-17
65034	SUPPL	2020-10-27
64991	SUPPL	2020-10-23
62110	SUPPL	2020-03-10
62103	SUPPL	2020-03-10
60111	SUPPL	2019-09-25
60096	SUPPL	2019-09-25
56167	ORIG	2018-10-29
55960	ORIG	2018-10-16
55956	ORIG	2018-10-16

Application 211651

Related Records#

Application Products#

NDC Listings For This Application#

Documents#