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 43.

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-002	RUBRACA	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2016-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-003	RUBRACA	EQ 250MG BASE	TABLET / ORAL	RLD	2017-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-001	RUBRACA	EQ 200MG BASE	TABLET / ORAL	RLD	2016-12-19	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 80 · 3,171 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209115-001	8071579	2027-08-12	U-2273		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8071579	2027-08-12	U-2012		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8071579	2027-08-12	U-2830		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8143241	2027-08-12	U-2012		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8143241	2027-08-12	U-2273		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8143241	2027-08-12	U-2830		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	10278974	2031-02-10		Drug product	2019-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	9861638	2031-02-10	U-2012		2018-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	9861638	2031-02-10	U-2273		2018-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8859562	2031-08-04	U-2012		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8859562	2031-08-04	U-2273		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	8859562	2031-08-04	U-2830		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	10130636	2035-08-17	U-2273		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	10130636	2035-08-17	U-2101		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	10130636	2035-08-17	U-2012		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	10130636	2035-08-17	U-2830		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-001	9987285	2035-08-17		Drug product	2018-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8071579	2027-08-12	U-2273		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8071579	2027-08-12	U-2012		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8071579	2027-08-12	U-2830		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8143241	2027-08-12	U-2012		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8143241	2027-08-12	U-2273		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8143241	2027-08-12	U-2830		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	10278974	2031-02-10		Drug product	2019-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8754072	2031-02-10		Drug substance, Drug product	2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	9045487	2031-02-10		Drug substance, Drug product	2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	9861638	2031-02-10	U-2012		2018-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	9861638	2031-02-10	U-2273		2018-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8859562	2031-08-04	U-2273		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8859562	2031-08-04	U-2012		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	8859562	2031-08-04	U-2830		2016-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	10130636	2035-08-17	U-2101		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	10130636	2035-08-17	U-2273		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	10130636	2035-08-17	U-2012		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	10130636	2035-08-17	U-2830		2018-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	9987285	2035-08-17		Drug product	2018-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-003	8071579	2027-08-12	U-2012		2017-05-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-003	8071579	2027-08-12	U-2273		2017-05-09	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 300 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N209115-001	I-982	2028-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-002	I-982	2028-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209115-003	I-982	2028-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209115-001	I-982	2028-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209115-002	I-982	2028-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209115-003	I-982	2028-12-17	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-001	ODE-168	2025-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-002	ODE-168	2025-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209115-003	ODE-168	2025-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209115-001	ODE-168	2025-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-002	ODE-168	2025-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209115-003	ODE-168	2025-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-001	ODE-168	2025-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-002	ODE-168	2025-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209115-003	ODE-168	2025-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-001	ODE-168	2025-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-002	ODE-168	2025-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209115-003	ODE-168	2025-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-001	ODE-168	2025-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-002	ODE-168	2025-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209115-003	ODE-168	2025-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-001	ODE-168	2025-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-002	ODE-168	2025-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209115-003	ODE-168	2025-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-001	ODE-168	2025-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-002	ODE-168	2025-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209115-003	ODE-168	2025-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-001	ODE-168	2025-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-002	ODE-168	2025-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209115-003	ODE-168	2025-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209115-001	ODE-168	2025-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-002	ODE-168	2025-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209115-003	ODE-168	2025-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-001	ODE-168	2025-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-002	ODE-168	2025-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209115-003	ODE-168	2025-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-001	ODE-168	2025-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-002	ODE-168	2025-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209115-003	ODE-168	2025-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209115-001	ODE-168	2025-04-06	`1e350fbaab3a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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