Home Applications 208065 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 43 .
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.
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 25 · 968 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 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…2026-09-14 22:38:34 2026-08 N208065-001 8946235 2032-08-08 U-1777 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 8946235 2032-08-08 U-2289 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 8946235 2032-08-08 U-3016 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 8946235 2032-08-08 U-4010 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 8946235 2032-08-08 U-3823 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 10183020 2035-01-02 U-1777 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 10183020 2035-01-02 U-3016 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 10183020 2035-01-02 U-4010 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 10183020 2035-01-02 U-2289 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 10183020 2035-01-02 U-3823 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-001 12465608 2042-11-26 U-3823 2025-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 8946235 2032-08-08 U-2289 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 8946235 2032-08-08 U-1777 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 8946235 2032-08-08 U-3016 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 8946235 2032-08-08 U-4010 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 8946235 2032-08-08 U-3823 Drug substance, Drug product 2015-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 10183020 2035-01-02 U-1777 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 10183020 2035-01-02 U-2289 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 10183020 2035-01-02 U-3016 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 10183020 2035-01-02 U-4010 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 10183020 2035-01-02 U-3823 Drug product 2019-02-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N208065-002 12465608 2042-11-26 U-3823 2025-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208065-001 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208065-001 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208065-001 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208065-001 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208065-001 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208065-001 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 304 observed states.
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