Application 204644

Type: ANDA
Sponsor: MYLAN

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 1.

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
A204644-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2017-06-21
A204644-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2017-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204644-001	AB
A204644-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204644-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2017-06-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204644-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2017-06-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204644-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204644-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204644-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204644-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204644-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204644-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204644-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204644-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204644-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204644-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204644-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204644-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204644-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204644-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204644-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204644-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204644-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204644-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204644-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204644-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204644-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204644-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204644-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204644-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204644-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204644-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204644-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204644-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib Mesylate	IMATINIB	Golden State Medical Supply, Inc.	9131b2ce-752d-3a30-e053-2a95a90adaab	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644 ndc (product): 51407-269 ndc (product): 51407-270
Imatinib Mesylate	IMATINIB	Mylan Pharmaceuticals Inc.	a1787fad-3612-43e1-98fa-ce62361e0b3c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644 ndc (product): 0378-2246 ndc (product): 0378-2245
Imatinib Mesylate	IMATINIB	Safecor Health, LLC	f4acacbd-13f8-4a46-b615-b639a17f331f	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644
Imatinib Mesylate	IMATINIB	Mylan Institutional Inc	1debf3a0-7587-47d7-8ea6-e739698d7297	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204644 application number: ANDA204644 ndc (product): 42292-044 ndc (product): 42292-043

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
0378-2245	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2245	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2245	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2245	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2245	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2245	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2246	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2246	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2246	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2246	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2246	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2246	Imatinib Mesylate	imatinib	Mylan Pharmaceuticals Inc.	ANDA	Current
42292-043	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-043	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-043	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-043	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-043	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-044	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-044	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-044	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-044	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
42292-044	Imatinib Mesylate	imatinib	Mylan Institutional Inc.	ANDA	Current
51407-269	Imatinib Mesylate	imatinib	Golden State Medical Supply Inc.	ANDA	Current
51407-269	Imatinib Mesylate	imatinib	Golden State Medical Supply	ANDA	Current
51407-269	Imatinib Mesylate	imatinib	Golden State Medical Supply	ANDA	Current
51407-269	Imatinib Mesylate	imatinib	Golden State Medical Supply, Inc.	ANDA	Current
51407-270	Imatinib Mesylate	imatinib	Golden State Medical Supply Inc.	ANDA	Current
51407-270	Imatinib Mesylate	imatinib	Golden State Medical Supply	ANDA	Current
51407-270	Imatinib Mesylate	imatinib	Golden State Medical Supply	ANDA	Current
51407-270	Imatinib Mesylate	imatinib	Golden State Medical Supply, Inc.	ANDA	Current