Application 209115

Type: NDA
Sponsor: CLOVIS ONCOLOGY INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RUBRACA	RUCAPARIB CAMSYLATE	TABLET;ORAL	EQ 200MG BASE	Yes	No
002	RUBRACA	RUCAPARIB CAMSYLATE	TABLET;ORAL	EQ 300MG BASE	Yes	Yes
003	RUBRACA	RUCAPARIB CAMSYLATE	TABLET;ORAL	EQ 250MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209115-001	RUBRACA	RUCAPARIB CAMSYLATE	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19
N209115-002	RUBRACA	RUCAPARIB CAMSYLATE	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19
N209115-003	RUBRACA	RUCAPARIB CAMSYLATE	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01

Orange Book patents#

Current patent rows page 1 of 1 · 57 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209115-001	8071579	2027-08-12	U-2012		2016-12-21
N209115-001	8071579	2027-08-12	U-2273		2016-12-21
N209115-001	8071579	2027-08-12	U-2830		2016-12-21
N209115-001	8143241	2027-08-12	U-2012		2016-12-21
N209115-001	8143241	2027-08-12	U-2273		2016-12-21
N209115-001	8143241	2027-08-12	U-2830		2016-12-21
N209115-001	10278974	2031-02-10		Drug product	2019-06-04
N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-001	9861638	2031-02-10	U-2012		2018-02-06
N209115-001	9861638	2031-02-10	U-2273		2018-02-06
N209115-001	8859562	2031-08-04	U-2012		2016-12-21
N209115-001	8859562	2031-08-04	U-2273		2016-12-21
N209115-001	8859562	2031-08-04	U-2830		2016-12-21
N209115-001	10130636	2035-08-17	U-2012		2018-12-17
N209115-001	10130636	2035-08-17	U-2101		2018-12-17
N209115-001	10130636	2035-08-17	U-2273		2018-12-17
N209115-001	10130636	2035-08-17	U-2830		2018-12-17
N209115-001	9987285	2035-08-17		Drug product	2018-06-28
N209115-002	8071579	2027-08-12	U-2012		2016-12-21
N209115-002	8071579	2027-08-12	U-2273		2016-12-21
N209115-002	8071579	2027-08-12	U-2830		2016-12-21
N209115-002	8143241	2027-08-12	U-2012		2016-12-21
N209115-002	8143241	2027-08-12	U-2273		2016-12-21
N209115-002	8143241	2027-08-12	U-2830		2016-12-21
N209115-002	10278974	2031-02-10		Drug product	2019-06-04
N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21
N209115-002	9861638	2031-02-10	U-2012		2018-02-06
N209115-002	9861638	2031-02-10	U-2273		2018-02-06
N209115-002	8859562	2031-08-04	U-2012		2016-12-21
N209115-002	8859562	2031-08-04	U-2273		2016-12-21
N209115-002	8859562	2031-08-04	U-2830		2016-12-21
N209115-002	10130636	2035-08-17	U-2012		2018-12-17
N209115-002	10130636	2035-08-17	U-2101		2018-12-17
N209115-002	10130636	2035-08-17	U-2273		2018-12-17
N209115-002	10130636	2035-08-17	U-2830		2018-12-17
N209115-002	9987285	2035-08-17		Drug product	2018-06-28
N209115-003	8071579	2027-08-12	U-2012		2017-05-09
N209115-003	8071579	2027-08-12	U-2273		2017-05-09
N209115-003	8071579	2027-08-12	U-2830		2017-05-09
N209115-003	8143241	2027-08-12	U-2012		2017-05-09
N209115-003	8143241	2027-08-12	U-2273		2017-05-09
N209115-003	8143241	2027-08-12	U-2830		2017-05-09
N209115-003	10278974	2031-02-10		Drug product	2019-06-04
N209115-003	8754072	2031-02-10		Drug substance, Drug product	2017-05-09
N209115-003	9045487	2031-02-10		Drug substance, Drug product	2017-05-09
N209115-003	9861638	2031-02-10	U-2012		2018-02-06
N209115-003	9861638	2031-02-10	U-2273		2018-02-06
N209115-003	8859562	2031-08-04	U-2012		2017-05-09
N209115-003	8859562	2031-08-04	U-2273		2017-05-09
N209115-003	8859562	2031-08-04	U-2830		2017-05-09
N209115-003	10130636	2035-08-17	U-2012		2018-12-17
N209115-003	10130636	2035-08-17	U-2101		2018-12-17
N209115-003	10130636	2035-08-17	U-2273		2018-12-17
N209115-003	10130636	2035-08-17	U-2830		2018-12-17
N209115-003	9987285	2035-08-17		Drug product	2018-06-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209115-001	I-982	2028-12-17
N209115-002	I-982	2028-12-17
N209115-003	I-982	2028-12-17

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209115-001	8071579	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8071579	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8071579	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8143241	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8143241	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8143241	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10278974	2031-02-10		Drug product	2019-06-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9861638	2031-02-10	U-2012		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9861638	2031-02-10	U-2273		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8859562	2031-08-04	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8859562	2031-08-04	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	8859562	2031-08-04	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2273		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2101		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2012		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	10130636	2035-08-17	U-2830		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-001	9987285	2035-08-17		Drug product	2018-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8071579	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8071579	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8071579	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8143241	2027-08-12	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8143241	2027-08-12	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8143241	2027-08-12	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10278974	2031-02-10		Drug product	2019-06-04	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9861638	2031-02-10	U-2012		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9861638	2031-02-10	U-2273		2018-02-06	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8859562	2031-08-04	U-2273		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8859562	2031-08-04	U-2012		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	8859562	2031-08-04	U-2830		2016-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2101		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2273		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2012		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	10130636	2035-08-17	U-2830		2018-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	9987285	2035-08-17		Drug product	2018-06-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	8071579	2027-08-12	U-2012		2017-05-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	8071579	2027-08-12	U-2273		2017-05-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N209115-001	I-982	2028-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-002	I-982	2028-12-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209115-003	I-982	2028-12-17	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rubraca	RUCAPARIB	pharmaand GmbH	0295d202-1cfe-7659-e063-6294a90a476e	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209115 application number: NDA209115

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69660-201	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-201	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-201	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-201	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-201	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-201	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-202	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-202	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-202	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-202	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-202	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-202	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-203	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-203	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-203	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-203	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-203	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current
69660-203	Rubraca	rucaparib	Clovis Oncology, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84484	SUPPL	2025-12-22
84483	SUPPL	2025-12-22
84469	SUPPL	2025-12-19
84468	SUPPL	2025-12-19
73010	SUPPL	2022-12-23
72997	SUPPL	2022-12-22
71270	SUPPL	2022-06-13
71269	SUPPL	2022-06-13
68868	SUPPL	2021-10-04
68856	SUPPL	2021-10-01
64904	SUPPL	2020-10-14
64885	SUPPL	2020-10-09
63092	SUPPL	2020-05-19
63052	SUPPL	2020-05-15
53658	SUPPL	2018-04-12
53633	SUPPL	2018-04-06
47024	ORIG	2017-01-30
46445	ORIG	2016-12-21
46206	ORIG	2016-12-19