Application 208558

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LYNPARZA	OLAPARIB	TABLET;ORAL	100MG	Yes	No
002	LYNPARZA	OLAPARIB	TABLET;ORAL	150MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208558-001	LYNPARZA	OLAPARIB	100MG	TABLET / ORAL		RLD	2017-08-17
N208558-002	LYNPARZA	OLAPARIB	150MG	TABLET / ORAL		RLD, RS	2017-08-17

Orange Book patents#

Current patent rows page 1 of 2 · 114 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208558-001	8071579	2027-08-12	U-2480		2020-06-18
N208558-001	8071579	2027-08-12	U-2482		2020-06-18
N208558-001	8071579	2027-08-12	U-2483		2020-06-18
N208558-001	8071579	2027-08-12	U-2716		2020-06-18
N208558-001	8071579	2027-08-12	U-2819		2020-06-18
N208558-001	8071579	2027-08-12	U-2820		2020-06-18
N208558-001	8071579	2027-08-12	U-2821		2020-06-18
N208558-001	8071579	2027-08-12	U-2822		2020-06-18
N208558-001	8071579	2027-08-12	U-2823		2020-06-18
N208558-001	8071579	2027-08-12	U-2824		2020-06-18
N208558-001	8071579	2027-08-12	U-2832		2020-06-18
N208558-001	8071579	2027-08-12	U-2833		2020-06-18
N208558-001	8071579	2027-08-12	U-3333		2020-06-18
N208558-001	8071579	2027-08-12	U-3631		2020-06-18
N208558-001	8071579	2027-08-12	U-3695		2020-06-18
N208558-001	8143241	2027-08-12	U-2480		2017-09-15
N208558-001	8143241	2027-08-12	U-2482		2017-09-15
N208558-001	8143241	2027-08-12	U-2483		2017-09-15
N208558-001	8143241	2027-08-12	U-2716		2017-09-15
N208558-001	8143241	2027-08-12	U-2819		2017-09-15
N208558-001	8143241	2027-08-12	U-2820		2017-09-15
N208558-001	8143241	2027-08-12	U-2821		2017-09-15
N208558-001	8143241	2027-08-12	U-2822		2017-09-15
N208558-001	8143241	2027-08-12	U-2823		2017-09-15
N208558-001	8143241	2027-08-12	U-2824		2017-09-15
N208558-001	8143241	2027-08-12	U-2832		2017-09-15
N208558-001	8143241	2027-08-12	U-2833		2017-09-15
N208558-001	8143241	2027-08-12	U-3333		2017-09-15
N208558-001	8143241	2027-08-12	U-3631		2017-09-15
N208558-001	8143241	2027-08-12	U-3695		2017-09-15
N208558-001	7449464	2027-09-08		Drug substance, Drug product	2017-09-15
N208558-001	11633396	2029-10-07		Drug product	2023-05-19
N208558-001	11975001	2029-10-07		Drug product	2024-06-03
N208558-001	12048695	2029-10-07		Drug product	2024-08-23
N208558-001	12144810	2029-10-07		Drug product	2024-12-10
N208558-001	12178816	2029-10-07		Drug product	2025-01-24
N208558-001	8475842	2029-12-31		Drug product	2017-09-15
N208558-001	8859562	2031-08-04	U-2101		2017-09-15
N208558-001	8859562	2031-08-04	U-2103		2017-09-15
N208558-001	8859562	2031-08-04	U-2480		2017-09-15
N208558-001	8859562	2031-08-04	U-2482		2017-09-15
N208558-001	8859562	2031-08-04	U-2483		2017-09-15
N208558-001	8859562	2031-08-04	U-2716		2017-09-15
N208558-001	8859562	2031-08-04	U-2819		2017-09-15
N208558-001	8859562	2031-08-04	U-2820		2017-09-15
N208558-001	8859562	2031-08-04	U-2821		2017-09-15
N208558-001	8859562	2031-08-04	U-2822		2017-09-15
N208558-001	8859562	2031-08-04	U-2823		2017-09-15
N208558-001	8859562	2031-08-04	U-2824		2017-09-15
N208558-001	8859562	2031-08-04	U-2832		2017-09-15
N208558-001	8859562	2031-08-04	U-2833		2017-09-15
N208558-001	8859562	2031-08-04	U-3333		2017-09-15
N208558-001	8859562	2031-08-04	U-3631		2017-09-15
N208558-001	8859562	2031-08-04	U-3695		2017-09-15
N208558-001	11970530	2041-10-25	U-3929		2024-05-28
N208558-001	11970530	2041-10-25	U-3930		2024-05-28
N208558-001	11970530	2041-10-25	U-3931		2024-05-28
N208558-002	8071579	2027-08-12	U-2480		2020-06-18
N208558-002	8071579	2027-08-12	U-2482		2020-06-18
N208558-002	8071579	2027-08-12	U-2483		2020-06-18
N208558-002	8071579	2027-08-12	U-2716		2020-06-18
N208558-002	8071579	2027-08-12	U-2819		2020-06-18
N208558-002	8071579	2027-08-12	U-2820		2020-06-18
N208558-002	8071579	2027-08-12	U-2821		2020-06-18
N208558-002	8071579	2027-08-12	U-2822		2020-06-18
N208558-002	8071579	2027-08-12	U-2823		2020-06-18
N208558-002	8071579	2027-08-12	U-2824		2020-06-18
N208558-002	8071579	2027-08-12	U-2832		2020-06-18
N208558-002	8071579	2027-08-12	U-2833		2020-06-18
N208558-002	8071579	2027-08-12	U-3333		2020-06-18
N208558-002	8071579	2027-08-12	U-3631		2020-06-18
N208558-002	8071579	2027-08-12	U-3695		2020-06-18
N208558-002	8143241	2027-08-12	U-2480		2017-09-15
N208558-002	8143241	2027-08-12	U-2482		2017-09-15
N208558-002	8143241	2027-08-12	U-2483		2017-09-15
N208558-002	8143241	2027-08-12	U-2716		2017-09-15
N208558-002	8143241	2027-08-12	U-2819		2017-09-15
N208558-002	8143241	2027-08-12	U-2820		2017-09-15
N208558-002	8143241	2027-08-12	U-2821		2017-09-15
N208558-002	8143241	2027-08-12	U-2822		2017-09-15

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208558-001	I-914	2026-05-31
N208558-001	ODE-283	2026-12-27
N208558-001	ODE-306	2027-05-08
N208558-002	I-914	2026-05-31
N208558-002	ODE-283	2026-12-27
N208558-002	ODE-306	2027-05-08

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208558-001	LYNPARZA	100MG	TABLET / ORAL	RLD	2017-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208558-002	LYNPARZA	150MG	TABLET / ORAL	RLD, RS	2017-08-17	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 123 · 4,893 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-3631		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2716		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2483		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2482		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-3695		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2820		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2824		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2833		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2823		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2832		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2480		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2821		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2819		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-2822		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8071579	2027-08-12	U-3333		2020-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2482		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2480		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2716		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2483		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-3631		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2824		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2823		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2821		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2819		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2820		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2822		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-3695		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2832		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-2833		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8143241	2027-08-12	U-3333		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	7449464	2027-09-08		Drug substance, Drug product	2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	11633396	2029-10-07		Drug product	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	11975001	2029-10-07		Drug product	2024-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	12048695	2029-10-07		Drug product	2024-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	12144810	2029-10-07		Drug product	2024-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	12178816	2029-10-07		Drug product	2025-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8475842	2029-12-31		Drug product	2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8859562	2031-08-04	U-2101		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8859562	2031-08-04	U-2483		2017-09-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	8859562	2031-08-04	U-2482		2017-09-15	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 644 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208558-001	I-914	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	ODE-283	2026-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-001	ODE-306	2027-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	I-914	2026-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	ODE-283	2026-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208558-002	ODE-306	2027-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	I-885	2025-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	ODE-226	2025-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	I-914	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	ODE-283	2026-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-001	ODE-306	2027-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	I-885	2025-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	ODE-226	2025-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	I-914	2026-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	ODE-283	2026-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208558-002	ODE-306	2027-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208558-001	I-885	2025-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	ODE-226	2025-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	I-914	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	ODE-283	2026-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-001	ODE-306	2027-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	I-885	2025-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	ODE-226	2025-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	I-914	2026-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	ODE-283	2026-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208558-002	ODE-306	2027-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	I-885	2025-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	ODE-226	2025-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	I-914	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	ODE-283	2026-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-001	ODE-306	2027-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	I-885	2025-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	ODE-226	2025-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	I-914	2026-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	ODE-283	2026-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208558-002	ODE-306	2027-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	I-885	2025-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	ODE-226	2025-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	I-914	2026-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208558-001	ODE-283	2026-12-27	`b8a1b40f171c…`

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
Lynparza	OLAPARIB	AstraZeneca Pharmaceuticals LP	741ff3e3-dc1a-45a6-84e5-2481b27131aa	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208558 application number: NDA208558 ndc (product): 0310-0668 ndc (product): 0310-0679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0668	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-0679	Lynparza	olaparib	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82820	SUPPL	2025-07-11
82819	SUPPL	2025-07-11
82804	SUPPL	2025-07-11
82790	SUPPL	2025-07-11
76526	SUPPL	2023-11-08
76521	SUPPL	2023-11-07
75422	SUPPL	2023-09-13
75415	SUPPL	2023-09-13
74421	SUPPL	2023-06-01
74415	SUPPL	2023-06-01
72511	SUPPL	2022-10-31
72510	SUPPL	2022-10-31
72493	SUPPL	2022-10-28
71953	SUPPL	2022-08-29
71952	SUPPL	2022-08-29
71939	SUPPL	2022-08-29
70505	SUPPL	2022-03-14
70500	SUPPL	2022-03-11
70499	SUPPL	2022-03-11
70054	SUPPL	2022-02-02
70053	SUPPL	2022-02-02
70026	SUPPL	2022-02-01
66772	SUPPL	2021-03-12
66771	SUPPL	2021-03-12
66770	SUPPL	2021-03-12
66758	SUPPL	2021-03-12
66757	SUPPL	2021-03-12
65564	SUPPL	2020-12-10
65563	SUPPL	2020-12-10
65532	SUPPL	2020-12-09
65171	SUPPL	2020-11-09
65136	SUPPL	2020-11-03
65135	SUPPL	2020-11-03
63152	SUPPL	2020-05-20
63151	SUPPL	2020-05-19
63150	SUPPL	2020-05-19
62887	SUPPL	2020-05-11
62860	SUPPL	2020-05-08
62859	SUPPL	2020-05-08
61467	SUPPL	2020-01-10
61468	SUPPL	2019-12-30
61466	SUPPL	2019-12-30
60568	SUPPL	2019-10-15
59292	SUPPL	2019-07-09
59291	SUPPL	2019-07-09
59205	SUPPL	2019-07-02
56948	SUPPL	2018-12-21
56808	SUPPL	2018-12-19
55760	SUPPL	2018-10-01
55633	SUPPL	2018-09-27
55632	SUPPL	2018-09-27
52493	SUPPL	2018-02-07
51059	SUPPL	2018-01-17
51041	SUPPL	2018-01-12
49660	ORIG	2017-09-05
49493	ORIG	2017-08-21
49444	ORIG	2017-08-17
49443	ORIG	2017-08-17