Application 207495

Type: ANDA
Sponsor: AMNEAL PHARMS

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 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
A207495-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL			2019-02-08
A207495-002	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-02-08	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207495-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL		2019-02-08	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207495-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL		2019-02-08	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A207495-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207495-002	AB	1	`ea99ee380514…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib Mesylate	IMATINIB MESYLATE	Apotex Corp	0291eca5-7a1d-4a79-30be-252224d96509	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB MESYLATE	QUALLENT PHARMACEUTICALS HEALTH LLC	a819a954-41c9-4d49-a74e-c8c4b338b22a	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB MESYLATE	Major Pharmaceuticals	7c037022-7fc8-4b6e-9db3-427206c572b4	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB MESYLATE	Aurobindo Pharma Limited	a4e409f7-20b4-4c80-8a6a-f95995ffad78	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB	Mylan Pharmaceuticals Inc.	a1787fad-3612-43e1-98fa-ce62361e0b3c	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate
Gleevec	IMATINIB MESYLATE	Novartis Pharmaceuticals Corporation	211ef2da-2868-4a77-8055-1cb2cd78e24b	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: IMATINIB MESYLATE
IMATINIB MESYLATE	IMATINIB MESYLATE	Civica Script LLC	9fc5ec7b-98c4-4b1a-890c-be1343177dbd	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: IMATINIB MESYLATE generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB	Golden State Medical Supply, Inc.	9131b2ce-752d-3a30-e053-2a95a90adaab	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate
imatinib mesylate	IMATINIB MESYLATE	Sun Pharmaceutical Industries, Inc.	07764bf9-21b4-4e32-9d7e-e348f8e4291f	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: imatinib mesylate generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB	Safecor Health, LLC	f4acacbd-13f8-4a46-b615-b639a17f331f	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate
imatinib mesylate	IMATINIB MESYLATE	Upsher-Smith Laboratories, LLC	5d07ac08-962e-41a8-8a3c-50febc8c5f34	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: imatinib mesylate generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB MESYLATE	Chartwell RX, LLC	65b4d8a6-349d-4fb1-9818-dad6b4ad4fa1	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate generic name: IMATINIB MESYLATE
IMATINIB MESYLATE	IMATINIB MESYLATE	Camber Pharmaceuticals, Inc.	e97f0238-b9da-46af-83a3-0826e39893e8	2025-11-25	Warnings, Adverse reactions	Name fallback brand name: IMATINIB MESYLATE generic name: IMATINIB MESYLATE
Imatinib Mesylate	IMATINIB	Mylan Institutional Inc	1debf3a0-7587-47d7-8ea6-e739698d7297	2025-09-15	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate
Imatinib Mesylate	IMATINIB MESYLATE	American Health Packaging	6e7ed4ef-24e3-4545-9a99-2e34c946e8e7	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Imatinib Mesylate generic name: IMATINIB MESYLATE
imatinib mesylate	IMATINIB MESYLATE	Qilu Pharmaceutical Co., Ltd.	82eb01e0-8685-4f06-8a72-7663e8ded38f	2024-12-04	Warnings, Adverse reactions	Name fallback brand name: imatinib mesylate generic name: IMATINIB MESYLATE
imatinib mesylate	IMATINIB MESYLATE	BluePoint Laboratories	be5b9047-155b-59ca-e053-2995a90ad3dc	2023-09-21	Warnings, Adverse reactions	Name fallback brand name: imatinib mesylate generic name: IMATINIB MESYLATE
imatinib mesylate	IMATINIB MESYLATE	Archis Pharma LLC	9de8d8b9-cf88-4960-82b7-89e5ceb7720e	2023-09-21	Warnings, Adverse reactions	Name fallback brand name: imatinib mesylate generic name: IMATINIB MESYLATE
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

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65162-794	Imatinib Mesylate	Imatinib	Amneal Pharmaceuticals LLC	ANDA	Current
65162-794	Imatinib Mesylate	Imatinib	Amneal Pharmaceuticals LLC	ANDA	Current
65162-794	Imatinib Mesylate	Imatinib	Amneal Pharmaceuticals LLC	ANDA	Current
65162-795	Imatinib Mesylate	Imatinib	Amneal Pharmaceuticals LLC	ANDA	Current
65162-795	Imatinib Mesylate	Imatinib	Amneal Pharmaceuticals LLC	ANDA	Current
65162-795	Imatinib Mesylate	Imatinib	Amneal Pharmaceuticals LLC	ANDA	Current