Application 205990

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMATINIB MESYLATE	IMATINIB MESYLATE	TABLET;ORAL	EQ 100MG BASE	No	No
002	IMATINIB MESYLATE	IMATINIB MESYLATE	TABLET;ORAL	EQ 400MG BASE	No	No

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
A205990-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL			2019-02-08
A205990-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL			2019-02-08

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205990-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205990-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205990-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205990-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205990-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205990-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205990-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205990-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205990-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205990-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205990-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205990-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205990-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205990-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205990-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205990-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205990-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205990-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205990-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205990-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205990-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205990-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205990-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205990-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205990-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205990-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205990-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205990-002	AB	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205990-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205990-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205990-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205990-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205990-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205990-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205990-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205990-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205990-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A205990-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205990-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205990-002	AB	1	`cb3db0bc1861…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib mesylate 400 mg	IMATINIB MESYLATE	Armas Pharmaceuticals Inc.	7b7cc194-29e4-4484-a364-a1ac7d7d6cf5	2019-03-08	Warnings, Adverse reactions	Name fallback generic name: IMATINIB MESYLATE
Imatinib mesylate	IMATINIB MESYLATE	Armas Pharmaceuticals Inc.	2e931c49-6c9f-41e2-a34b-5f01cd295b56	2019-03-04	Warnings, Adverse reactions	Name fallback brand name: Imatinib mesylate generic name: IMATINIB MESYLATE
Imatinib mesylate	IMATINIB MESYLATE	Ascend Laboratories, LLC	7579620e-3748-46fa-8295-f9b47d0aa5b8	2019-02-01	Warnings, Adverse reactions	Name fallback brand name: Imatinib mesylate generic name: IMATINIB MESYLATE

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-376	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-376	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-376	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-376	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-376	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-377	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-377	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-377	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-377	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-377	IMATINIB MESYLATE	IMATINIB MESYLATE	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63629-2067	IMATINIB MESYLATE	IMATINIB MESYLATE	Bryant Ranch Prepack	ANDA	Current
63629-2067	IMATINIB MESYLATE	IMATINIB MESYLATE	Bryant Ranch Prepack	ANDA	Current
63629-2067	IMATINIB MESYLATE	IMATINIB MESYLATE	Bryant Ranch Prepack	ANDA	Current
63629-2068	IMATINIB MESYLATE	IMATINIB MESYLATE	Bryant Ranch Prepack	ANDA	Current
63629-2068	IMATINIB MESYLATE	IMATINIB MESYLATE	Bryant Ranch Prepack	ANDA	Current
63629-2068	IMATINIB MESYLATE	IMATINIB MESYLATE	Bryant Ranch Prepack	ANDA	Current