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 44.

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208065-001	TAGRISSO	EQ 40MG BASE	TABLET / ORAL	RLD	2015-11-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208065-002	TAGRISSO	EQ 80MG BASE	TABLET / ORAL	RLD, RS	2015-11-13	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,002 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N208065-001	11524951	2032-07-25		Drug substance, Drug product	2023-01-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	8946235	2032-08-08	U-1777	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	8946235	2032-08-08	U-2289	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	8946235	2032-08-08	U-3016	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	8946235	2032-08-08	U-4010	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	8946235	2032-08-08	U-3823	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	10183020	2035-01-02	U-1777	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	10183020	2035-01-02	U-3016	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	10183020	2035-01-02	U-4010	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	10183020	2035-01-02	U-2289	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	10183020	2035-01-02	U-3823	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	12465608	2042-11-26	U-3823		2025-12-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	11524951	2032-07-25		Drug substance, Drug product	2023-01-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	8946235	2032-08-08	U-2289	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	8946235	2032-08-08	U-1777	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	8946235	2032-08-08	U-3016	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	8946235	2032-08-08	U-4010	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	8946235	2032-08-08	U-3823	Drug substance, Drug product	2015-12-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	10183020	2035-01-02	U-1777	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	10183020	2035-01-02	U-2289	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	10183020	2035-01-02	U-3016	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	10183020	2035-01-02	U-4010	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	10183020	2035-01-02	U-3823	Drug product	2019-02-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	12465608	2042-11-26	U-3823		2025-12-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208065-001	11524951	2032-07-25		Drug substance, Drug product	2023-01-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	9732058	2032-07-25	U-1777	Drug substance, Drug product	2017-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	9732058	2032-07-25	U-2289	Drug substance, Drug product	2017-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	9732058	2032-07-25	U-3016	Drug substance, Drug product	2017-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	9732058	2032-07-25	U-4010	Drug substance, Drug product	2017-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	9732058	2032-07-25	U-3823	Drug substance, Drug product	2017-08-29	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 8 · 310 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N208065-001	I-941	2027-02-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	I-952	2027-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-001	ODE-337	2027-12-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	I-941	2027-02-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	I-952	2027-09-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N208065-002	ODE-337	2027-12-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N208065-001	I-941	2027-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	I-952	2027-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-001	ODE-337	2027-12-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-002	I-941	2027-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-002	I-952	2027-09-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208065-002	ODE-337	2027-12-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208065-001	I-941	2027-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208065-001	I-952	2027-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208065-001	ODE-337	2027-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208065-002	I-941	2027-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208065-002	I-952	2027-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208065-002	ODE-337	2027-12-18	`caaa826d4ba7…`
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…`

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 · 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