Application 021399

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IRESSA	GEFITINIB	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021399-001	IRESSA	GEFITINIB	250MG	TABLET / ORAL			2003-05-05

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021399-001	IRESSA	250MG	TABLET / ORAL	2003-05-05	`f41ea6bd6efb…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gefitinib	GEFITINIB	Natco Pharma USA LLC	1a3c0ce7-06a1-4e04-9106-14ddb2a866a5	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: GEFITINIB
Gefitinib	GEFITINIB	Ingenus Pharmaceuticals, LLC	6402435f-9f6a-4f02-91a2-6267d783fa78	2023-12-28	Warnings, Adverse reactions	Name fallback generic name: GEFITINIB
IRESSA	GEFITINIB	AstraZeneca Pharmaceuticals LP	827d60e8-7e07-41b7-c28b-49ef1c4a5a41	2023-02-28	Warnings, Adverse reactions	Name fallback brand name: IRESSA generic name: GEFITINIB
Gefitinib	GEFITINIB	Qilu Pharmaceutical Co., Ltd.	0afc12dd-12f8-4def-9027-f38412a862b9	2023-02-22	Warnings, Adverse reactions	Name fallback generic name: GEFITINIB
Gefitinib	GEFITINIB	Teva Pharmaceuticals, Inc.	3dd135f0-5db1-4236-9756-04533b66dc9d	2022-02-01	Warnings, Adverse reactions	Name fallback generic name: GEFITINIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
5251	SUPPL	2005-06-21
15363	SUPPL	2005-06-17
5250	SUPPL	2004-12-02
27667	ORIG	2004-06-07
27668	SUPPL	2004-05-07
15362	SUPPL	2004-05-07
21636	ORIG	2003-07-15
36818	ORIG	2003-05-05