Application 208065

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAGRISSO	OSIMERTINIB MESYLATE	TABLET;ORAL	EQ 40MG BASE	Yes	No
002	TAGRISSO	OSIMERTINIB MESYLATE	TABLET;ORAL	EQ 80MG BASE	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
N208065-001	TAGRISSO	OSIMERTINIB MESYLATE	EQ 40MG BASE	TABLET / ORAL		RLD	2015-11-13
N208065-002	TAGRISSO	OSIMERTINIB MESYLATE	EQ 80MG BASE	TABLET / ORAL		RLD, RS	2015-11-13

Orange Book patents#

Current patent rows page 1 of 1 · 34 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208065-001	11524951	2032-07-25		Drug substance, Drug product	2023-01-11
N208065-001	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29
N208065-001	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29
N208065-001	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29
N208065-001	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29
N208065-001	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29
N208065-001	8946235	2032-08-08	U-1777	Drug substance, Drug product	2015-12-11
N208065-001	8946235	2032-08-08	U-2289	Drug substance, Drug product	2015-12-11
N208065-001	8946235	2032-08-08	U-3016	Drug substance, Drug product	2015-12-11
N208065-001	8946235	2032-08-08	U-3823	Drug substance, Drug product	2015-12-11
N208065-001	8946235	2032-08-08	U-4010	Drug substance, Drug product	2015-12-11
N208065-001	10183020	2035-01-02	U-1777	Drug product	2019-02-12
N208065-001	10183020	2035-01-02	U-2289	Drug product	2019-02-12
N208065-001	10183020	2035-01-02	U-3016	Drug product	2019-02-12
N208065-001	10183020	2035-01-02	U-3823	Drug product	2019-02-12
N208065-001	10183020	2035-01-02	U-4010	Drug product	2019-02-12
N208065-001	12465608	2042-11-26	U-3823		2025-12-10
N208065-002	11524951	2032-07-25		Drug substance, Drug product	2023-01-11
N208065-002	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29
N208065-002	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29
N208065-002	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29
N208065-002	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29
N208065-002	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29
N208065-002	8946235	2032-08-08	U-1777	Drug substance, Drug product	2015-12-11
N208065-002	8946235	2032-08-08	U-2289	Drug substance, Drug product	2015-12-11
N208065-002	8946235	2032-08-08	U-3016	Drug substance, Drug product	2015-12-11
N208065-002	8946235	2032-08-08	U-3823	Drug substance, Drug product	2015-12-11
N208065-002	8946235	2032-08-08	U-4010	Drug substance, Drug product	2015-12-11
N208065-002	10183020	2035-01-02	U-1777	Drug product	2019-02-12
N208065-002	10183020	2035-01-02	U-2289	Drug product	2019-02-12
N208065-002	10183020	2035-01-02	U-3016	Drug product	2019-02-12
N208065-002	10183020	2035-01-02	U-3823	Drug product	2019-02-12
N208065-002	10183020	2035-01-02	U-4010	Drug product	2019-02-12
N208065-002	12465608	2042-11-26	U-3823		2025-12-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N208065-001	I-941	2027-02-16
N208065-001	I-952	2027-09-25
N208065-001	ODE-337	2027-12-18
N208065-002	I-941	2027-02-16
N208065-002	I-952	2027-09-25
N208065-002	ODE-337	2027-12-18

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	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 23 · 900 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	N208065-001	11524951	2032-07-25		Drug substance, Drug product	2023-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	8946235	2032-08-08	U-1777	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	8946235	2032-08-08	U-2289	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	8946235	2032-08-08	U-3016	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	8946235	2032-08-08	U-4010	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	8946235	2032-08-08	U-3823	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	10183020	2035-01-02	U-1777	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	10183020	2035-01-02	U-3016	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	10183020	2035-01-02	U-4010	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	10183020	2035-01-02	U-2289	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	10183020	2035-01-02	U-3823	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	12465608	2042-11-26	U-3823		2025-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	11524951	2032-07-25		Drug substance, Drug product	2023-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	8946235	2032-08-08	U-2289	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	8946235	2032-08-08	U-1777	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	8946235	2032-08-08	U-3016	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	8946235	2032-08-08	U-4010	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	8946235	2032-08-08	U-3823	Drug substance, Drug product	2015-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	10183020	2035-01-02	U-1777	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	10183020	2035-01-02	U-2289	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	10183020	2035-01-02	U-3016	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	10183020	2035-01-02	U-4010	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	10183020	2035-01-02	U-3823	Drug product	2019-02-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	12465608	2042-11-26	U-3823		2025-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	11524951	2032-07-25		Drug substance, Drug product	2023-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 292 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	N208065-001	I-941	2027-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	I-952	2027-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-001	ODE-337	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	I-941	2027-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	I-952	2027-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208065-002	ODE-337	2027-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	ODE-176	2025-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	I-941	2027-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	I-952	2027-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-001	ODE-337	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-002	ODE-176	2025-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-002	I-941	2027-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-002	I-952	2027-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208065-002	ODE-337	2027-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208065-001	ODE-176	2025-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-001	I-941	2027-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-001	I-952	2027-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-001	ODE-337	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-002	ODE-176	2025-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-002	I-941	2027-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-002	I-952	2027-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208065-002	ODE-337	2027-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-001	ODE-176	2025-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-001	I-941	2027-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-001	I-952	2027-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-001	ODE-337	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-002	ODE-176	2025-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-002	I-941	2027-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-002	I-952	2027-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208065-002	ODE-337	2027-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-001	ODE-176	2025-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-001	I-941	2027-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-001	I-952	2027-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-001	ODE-337	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-002	ODE-176	2025-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-002	I-941	2027-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-002	I-952	2027-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208065-002	ODE-337	2027-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208065-001	ODE-176	2025-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208065-001	I-941	2027-02-16	`03ed91905a0d…`

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
TAGRISSO	OSIMERTINIB	AstraZeneca Pharmaceuticals LP	5e81b4a7-b971-45e1-9c31-29cea8c87ce7	2024-09-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208065 application number: NDA208065 ndc (product): 0310-1350 ndc (product): 0310-1349

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1349	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-1350	TAGRISSO	osimertinib	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79737	SUPPL	2024-09-26
79736	SUPPL	2024-09-26
78315	SUPPL	2024-04-30
78306	SUPPL	2024-04-30
77577	SUPPL	2024-02-20
77558	SUPPL	2024-02-16
77389	SUPPL	2024-02-02
77380	SUPPL	2024-02-01
74612	SUPPL	2023-06-22
74584	SUPPL	2023-06-22
72471	SUPPL	2022-10-26
72449	SUPPL	2022-10-24
72225	SUPPL	2022-10-03
72209	SUPPL	2022-10-03
69937	SUPPL	2022-01-20
69928	SUPPL	2022-01-20
68207	SUPPL	2021-07-27
68195	SUPPL	2021-07-27
65680	SUPPL	2020-12-22
65624	SUPPL	2020-12-18
65595	SUPPL	2020-12-15
65582	SUPPL	2020-12-14
65559	SUPPL	2020-12-10
65555	SUPPL	2020-12-10
63400	SUPPL	2020-06-02
63397	SUPPL	2020-06-02
61425	SUPPL	2019-12-23
61407	SUPPL	2019-12-23
55371	SUPPL	2018-08-30
55351	SUPPL	2018-08-29
53773	SUPPL	2018-04-23
53772	SUPPL	2018-04-23
53732	SUPPL	2018-04-19
50307	SUPPL	2017-11-06
50246	SUPPL	2017-10-31
47821	SUPPL	2017-04-03
47794	SUPPL	2017-03-30
47283	SUPPL	2017-02-22
45499	SUPPL	2016-09-30
45077	SUPPL	2016-08-17
45128	SUPPL	2016-08-12
23049	ORIG	2015-12-23
44971	ORIG	2015-12-11
19981	ORIG	2015-11-13
10641	ORIG	2015-11-13